Director of Human Factors Job Details | Olympus Corporation of the Americas
Olympus 4.6
Olympus job in Westborough, MA
Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: ***************************************
Job Description
This role supports the US R&D Team as both a leader of the OSTA HF team and as an Human Factors expert providing project support, mentoring and guidance in Human Factors and Usability Engineering processes, managing the creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company.
This role requires a committed strategic thinker, a collaborative teammate, a mentor and hands-on multi-disciplinary technical leader with a strong medical device background and excellent communication skills. This position leads the US Human Factors team, helps review documentation and Human Factors consultants to ensure Olympus HF activities are set up to succeed.
Job Duties
* Be the OSTA HF team leader and SME for Initiatives and Queries from leadership, other disciplines.
* Direct and lead multiple HFE projects or phases at any one given time leading the design and execution of formative and summative human factor studies of physical and digital medical devices.
* Direct and be hands on, should projects need it.
* Be the point of contact for regulatory body audits and communications for the region.
* Strategically plan OSTA Projects at times with project HF team member, determining required activities and level of effort, resourcing.
* Identify qualified HF Vendors for the region and shepherd process for HF Vendors to become engaged in projects.
* Ensure that human-system capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.
* Ensure that expert HFE input is provided to product design teams for addressing design requirements, packaging requirements, IFU's, etc in support of regulatory submissions.
* Collaborate with cross-functional leadership to develop and communicate a HFE practice vision and strategy.
* Establish and foster strong collaborative relationships with internal team members and external partners in the execution of HF activities.
* Support regional HF Team through team meetings, project resourcing analysis and solutioning.
* Coach HFE team members through mentorship, training, and career track development.
* Independently review HF work on projects to ensure best practices and compliance to regulatory body expectations.
* Determine regional budget needs.
Job Qualifications
Required:
* Bachelor's degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is a minimum requirement.
* Minimum years of HF experience: 8 years with a M.S. or 12 years with a B.S. degree in Human Factors or other related discipline.
* Minimum years of leadership experience: 4 years
* Medical Device experience is required.
* Proven experience in the Human Factors principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis.
* Thorough knowledge and expert understanding of the principles, standards and guidance for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff', Quality System Regulation (QSR), ISO 13485, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, AAMI.
* Experience on multiple projects with high-demand schedules and with complex, multi-functional development projects and cross-disciplinary teams.
* Experience leading a team of HFEs.
* Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs to track performance as it relates to usability goals.
* Experience in the design of formative and summative human factor studies to address usability requirements, context of use, verification and validation stages of medical device development.
* Experience writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports).
* Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Leadership, Strategic Thinking, Collaborative.
* Demonstrated time management, decision making, presentation, and organization skills.
* Excellent organizational, technical problem solving, negotiation, and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to manage external consultants.
* Works with global teams at times, availability will include working across the associated time zones.
* International and domestic travel up to 15% of the time.
Preferred:
* Master's degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area preferred.
* Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP) preferred.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: ******************************************************
The anticipated base pay range for this full-time position working at this location is $162,565.00 - $243,847.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ***********************
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development
$162.6k-243.8k yearly 60d+ ago
Looking for a job?
Let Zippia find it for you.
Senior Clinical Scientist (GIS) Job Details | Olympus Corporation of the Americas
Olympus 4.6
Olympus job in Westborough, MA
Workplace Flexibility: Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: ***************************************
Job Description
This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical studies in support of clinical evidence generation strategies across the GIS - Gastrointestinal Solutions Division; GI (including core GI, EUS, and Infection Prevention), EndoTherapy, Medical Service, and Endoscopic Solutions Ecosystem.
This individual will participate in the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus's portfolio. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study reports; will work closely with study sites to obtain necessary approvals (EC/IRB); and will respond critically to questions raised throughout the clinical study execution.
The individual is a critical member of Clinical Affairs strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across different business units, and within the broader Olympus organization, as appropriate.
Job Duties
* In collaboration with internal and external to MSA stakeholders, contribute to an evidence generation strategy that will drive the clinical evidence strategy for OLY business units
* Provides critical input into Business Development, R&D, and product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product's value proposition.
* Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
* Participate in clinical trial design (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting).
* Oversee execution of Investigator Initiated Trials (IIT) and Collaborative Clinical Research (CCR) initiatives.
* Present clinical study updates to internal and external stakeholders; support Publication strategies.
* Support Regulatory submissions.
* Facilitate communication between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites.
* Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
* Other duties as assigned.
Job Qualifications
Required:
* BA/BS degree in life sciences or related field.
* Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry.
* Experience working on evidence generation strategies.
* Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
* Demonstrated scientific writing ability.
* Ability to plan and organize project assignments of substantial variety and complexity.
* Ability to be innovative, resourceful, and work with minimal direction.
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
* Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff.
* Strong organizational and follow-up skills, as well as attention to detail.
* Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
* Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
* Domestic and international travel up to 5-10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
* Scheduling flexibility to commit to a global weekly schedule (Tuesday - Wednesday - Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.
Preferred:
* Advanced degree in life sciences, medicine or related field.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: ******************************************************
The anticipated base pay range for this full-time position is $114,467.00 - $160,254.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ***********************
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
$114.5k-160.3k yearly 48d ago
Associate Spine Specialist (Boston, MA)
Globus Medical 4.5
Boston, MA job
Associate Spine Specialist (Boston, MA) page is loaded## Associate Spine Specialist (Boston, MA)locations: Massachusettstime type: Full timeposted on: Posted 25 Days Agojob requisition id: JR104911At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible The Associate Spine Specialist will work together with the Spine Territory Manager and will have territory coverage, inventory management, and limited sales responsibilities. The Associate Spine Specialist will represent the company in accordance with the company's quality policy and procedures.**Essential Functions****:*** Gains and consistently increases product knowledge through formal sales training; surgeon speaker programs, attends surgeries/operating room visits, and industry research* Meeting or exceeds all sales goals and objectives assigned* Conducts sales calls to promote, sells, and services Globus Medical products and services to existing and competitive customers based on a strategic plan* Assists the Spine Territory Manager on field calls for assigned geography and address and problems that arise on the account* Performs field ride along with the Area Director and Spine Territory Manager on a regular basis* Develops and increases customer base and continually enhances Globus product market share within assigned territory* Provides feedback regularly on topics such as product development opportunities, new target accounts, sales performance, and market feedback* Maintains conduct that is aligned with company quality policy and procedures, and protects confidentiality with proprietary information* Stays current with all compliance training requirements* Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.* Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role* Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties*Reasonable accommodations may be made to enable individuals with disabilities to perform these* essential *functions.***Qualifications****:*** 1-2 years' successful spine sales experience preferred, may consider other healthcare related sales and or business to business sales experience* Bachelor's degree in Science or Business* Exemplary ability to listen, communicate and influence* Ability to travel as necessary, which may include nights and/or weekends* Strong understanding of spinal anatomy* Ability to make sales presentations with positive results**Physical Demands****:**The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.* Required to sit; climb or balance; and stoop, kneel, crouch or crawl* Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds* Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.**Our Values:**Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.* **Passionate about Innovation**: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.* **Customer Focused**: We listen to our customers' needs and respond with a sense of urgency.* **Teamwork**: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.* **Driven**: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. **Equal Employment Opportunity:**Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful. **Other Duties:**Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
#J-18808-Ljbffr
$75k-86k yearly est. 5d ago
Global VP R&D, Respiratory Job Details | Olympus Corporation of the Americas
Olympus 4.6
Olympus job in Westborough, MA
Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: ***************************************
Job Description
As part of the Surgical Interventional Solutions (SIS) division, the Global Vice President of R&D, Respiratory, will partner with the business unit leaders to drive the technology and product development strategy for the Olympus' respiratory solutions business unit. This executive will define and drive the innovation roadmap, oversee execution of new product development programs, and ensure alignment with business growth objectives and metrics.
The VP R&D Respiratory SIS, works across the global Olympus R&D groups, Product R&D Innovation Leaders, Respiratory BU leadership and Marketing teams to develop a strong New Product Development (NPD) portfolio pipeline as well as working with the Global Medical Project Management Organization (GPMO) and partnering with cross-functional teams to ensure new products are meeting all Key Performance Indicators (KPIs) related to Quality, Investment, Cost, Launch Schedules and Business metrics (QICD-B).
The VP R&D Respiratory will possess deep procedural and technical knowledge of products, technology trends, competitive products as well as focusing on disruptive opportunities in the minimally invasive procedures, respiratory field. This individual will also serve as the overall respiratory technology leader and will create and maintain strong relationships with the Health Care Professionals (HCPs, as well as foster technology advancements between the R&D teams and HCPs. Additionally, serves as the point of contact for the Respiratory Business Unit (BU) Leader and works to ensure the NPD pipeline is competitive and meets or exceeds the growth expectations for the Respiratory BU. This position oversees early-stage technology programs in Respiratory and works closely with internal development teams in Europe, Japan and United States to create disruptive innovations. This person will also develop external technology partners to explore and expedite commercialization of new technologies in the respiratory field.
The VP of R&D Respiratory role reports to the Global Head of R&D for the SIS Division and is a member of the Global SIS R&D leadership team and has full accountability of the Respiratory product portfolio. The VP R&D Respiratory will also serve as an integral part of inorganic business development acquisition strategies related to the Respiratory BU and provide additional oversight to due diligence activities and post-acquisition integration into R&D SIS division.
Job Duties
* Working closely with the BU leaders, develop and implement a comprehensive technology and product innovation strategy for the respiratory portfolio, ensuring a robust and competitive pipeline.
* Lead global R&D activities across multiple regions and functional teams, fostering collaboration between engineering, marketing, and business leadership.
* Oversee end-to-end product development from concept through commercialization, ensuring delivery on key metrics such as quality, cost, investment efficiency, and launch readiness.
* Identify and pursue disruptive technologies and emerging trends within the respiratory field, guiding internal and external innovation efforts.
* Build and maintain strong partnerships with clinicians, research institutions, and technology partners to accelerate innovation and strengthen clinical relevance.
* Provide technical and strategic leadership for inorganic growth opportunities, including due diligence and integration of acquired technologies or businesses.
* Partner closely with senior business leaders to align R&D investments with long-term business and market objectives.
* Cultivate a culture of innovation, accountability, and high performance within the R&D organization.
Job Qualifications
Required:
* BS Degree required.
* Minimum of 10 years of experience in medical device R&D or related healthcare technology fields, with a track record of leading global innovation and product development.
* Deep understanding of medical technology development processes, regulatory requirements, and commercialization pathways.
* Demonstrated success managing complex, cross-functional programs in a global organization.
* Strong leadership, communication, and collaboration skills with the ability to engage effectively across technical and business functions.
* Proven ability to identify strategic opportunities and translate them into executable innovation initiatives.
* Track record of working closely with key opinion leaders to bring innovative ideas into product development and ultimately to commercialization.
* Comfortable navigating ambiguity and driving accountability to finishing projects on schedule and budget.
* Large Program Management Experience working with global teams.
* Demonstrated communication skills both written and verbal.
* Computer proficiency e.g. Office 365, MS Office Suite (Outlook, PowerPoint, Excel, Word, SharePoint, Teams, etc.), SAP, JDE, Concur and web-based applications such as SharePoint a plus.
* Moderate International and Domestic Travel.
Preferred:
* MS Degree in engineering, life sciences, or a related technical discipline; preferred.
* Fluency in one or more of the following languages a plus: Japanese, German.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: ******************************************************
The anticipated base pay range for this full-time position working at this location is $210,319.00 - $336,510.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ***********************
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development
$210.3k-336.5k yearly 60d+ ago
Inventory Control Clerk
Globus Medical, Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
**Position Summary:**
The Inventory Associate will perform standard inventory warehouse functions. This includes picking items for orders, putting away inventory receipts and replenish inventory from bulk storage to a picking location.
**Essential Functions:**
- Processing all orders received in the same day for shipment
- Performing cycle counts on a daily basis to verify accurate system quantities as well as ensure shelf life of sterile products
- Bagging and bulk storing incoming inventory
- Replenishing items from a bulk to a picking location
- Picking items and sets to fulfill customer and in-house departmental requests
- Entering item data related to order transactions into the software system
- Maintaining Finish Goods Warehouse in a clean and orderly manner
- Maintaining inventory items in a first-in/first-out basis
- Identifying, picking, and organizing surgical sets from the proper location
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
_Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
**Qualifications:**
- High School diploma or equivalent
- Minimum one-year experience working in a Finished Goods Warehouse environment
- Ability to follow procedures as well as take initiative, team player
- Experience using Radio Frequency (RF) scanners
- Proficient computer skills (Microsoft Office)
- Strong communication, interpersonal skills
**Physical Demands:**
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$37k-43k yearly est. 34d ago
Director, External Research Programs
Olympus Corporation of The Americas 4.6
Olympus Corporation of The Americas job in Westborough, MA
**Working Location: MASSACHUSETTS, WESTBOROUGH** **Workplace Flexibility: Remote** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. _** **_ _** Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
**Patient Focus, Integrity, Innovation, Impact and Empathy.**
Learn more about Life at Olympus: ************************************** .
**Job Description**
This role is responsible for driving the successful execution of Olympus's External Research Program-including investigator-initiated trials, collaborative research, and real-world evidence projects-and for leading the development and optimization of scalable processes that support the creation of evidence generation strategies.
This individual oversees a team of clinical scientists and ensures that external research activities are executed with scientific rigor and operational excellence, while also establishing and refining the infrastructure needed to enable consistent, high-quality evidence planning across the organization.
This role is pivotal in shaping and executing Olympus's external research strategy, managing clinical strategy operations, and providing strong people leadership. This position requires an inspiring leader with a deep understanding of clinical research, external collaborations, and real-world evidence generation, who thrives in a dynamic and cross-functional environment.
The individual is a critical leader within the Clinical Research strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across different business units, and within the broader Olympus organization, as appropriate.
**Job Duties**
+ Manages execution of Olympus's External Research Program, ensuring studies are strategically designed to align with business priorities, efficiently run and scientifically impactful.
+ Leads and mentors a team of clinical scientists supporting external research and evidence generation activities; fosters a collaborative and process-driven culture that emphasizes scientific rigor, accountability, quality, and efficiency.
+ Provides guidance for clinical scientists on strategic elements of evidence generation strategy development and clinical trial design (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting).
+ Develops, implements, and continuously refines processes and tools for developing/managing evidence generation strategies and externally sponsored research.
+ Oversees process for review and approval of external research proposals, including intake, scientific and operational review, contracting, tracking, and deliverables.
+ Partners with cross-functional teams including Clinical Research leadership, legal, compliance, medical,and finance to facilitate seamless study start-up, execution, and closure.
+ Monitors portfolio-level metrics and provides reporting to leadership on program status, bottlenecks, and continuous improvement opportunities.
+ Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
+ Presents updates on the external research program to internal and external stakeholders; supports publication strategies.
+ Ensures studies conducted under the external research program framework are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
+ Other duties as assigned.
**Job Qualifications**
**Required:**
+ BA/BS degree in life sciences or related field.
+ Minimum of 10 years medical device industry experience post-degree preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry.
+ Minimum of 5 years of direct people management experience.
+ Experience leading externally sponsored research programs and developing evidence generation strategies that include investigator-initiated trials, collaborative research and real-world evidence.
+ Demonstrated track record of developing and implementing operational processes to support external research programs across multiple geographies.
+ Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory, Medical Affairs, and Clinical Operations.
+ Familiarity with relevant regulations and standards (e.g., GCP, GDPR, Sunshine Act, clinical trial transparency, research compliance).
+ Experience with research governance systems or platforms for intake, study tracking, and document management.
+ Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
+ Strong project and portfolio management skills, including use of tools for timelines, milestones, and performance metrics.
+ Excellent written and verbal communication skills, including the ability to engage with internal stakeholders and external investigators.
+ Strong organizational and follow-up skills, as well as attention to detail.
+ Strong consulting, facilitation, and communication skills bridging scientific and business priorities, to manage effective international and cross-divisional collaboration.
+ Domestic and international travel up to 5-10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
+ Scheduling flexibility to commit to a global weekly schedule (Tuesday - Wednesday - Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.
**Preferred:**
+ Advanced degree in life sciences, medicine or related field.
**Why join Olympus?**
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
**Equitable Offerings you can count on:**
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center**
**Connected Culture you can embrace:**
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
**Are you ready to be a part of our team?**
Learn more about our benefits and incentives: **************************************/benefits-perks .
The anticipated base pay range for this full-time position is $155,497.00 - $233,245.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ********************** .
**You Belong at Olympus**
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
**_Applicants Requesting Accommodations:_** Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
**Let's realize your potential, together.**
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
$155.5k-233.2k yearly 57d ago
GROUP ENGINEERING MANAGER - NAVIGATION HARDWARE
Globus Medical 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
We are seeking an experienced Systems Engineering and Hardware Systems Manager to lead a multidisciplinary team driving innovation in next-generation surgical navigation systems. This role requires deep expertise in mechanical and electrical engineering principles, ensuring robust hardware solutions and compliance with medical device standards while driving innovation in product development.
Essential Functions:
Mechanical & Electrical System Design
Lead development of hardware platforms, including mechanical and electrical subsystems, ensuring robust performance and reliability.
Design and development of mechanical assemblies, precision components, and electromechanical systems.
Drive electrical hardware design including PCB development, power systems, and sensor integration.
Systems Architecture & Integration
Define system-level architecture with strong emphasis on hardware reliability and performance.
Ensure seamless integration of mechanical and electrical subsystems into robust, reliable and cohesive surgical navigation platforms. Collaborate with software and clinical teams for full system integration.
Drive requirements management, risk analysis, and design verification/validation.
Leadership & Development
Recruit, mentor, and develop a high-performing team of systems and hardware engineers focused on mechanical, electrical, and integrated system design.
Foster a culture of innovation, collaboration, accountability and compliance with medical device standards. Ensure timely delivery of milestones within budget and quality standards.
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance pertaining to the role.
Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus.
Process & Compliance
Implement best practices in systems engineering, including requirements management, traceability, and design controls.
Ensure compliance with medical device standards (ISO 13485, IEC 60601, etc.) and regulatory guidelines.
Support design transfer from R&D to production under ISO 13485 and FDA guidelines.
Innovation & Continuous Improvement
Identify emerging technologies and incorporate them into product roadmaps.
Lead prototyping and feasibility studies for emerging navigation technologies.
Foster a culture of creativity and technical excellence within the team.
Promote IP development through patents and publications.
Reasonable accommodations may be made to enable individuals with disabilities to perform these
essential
functions.
Qualifications:
Master's degree or PhD in Mechanical Engineering, Electrical Engineering, or related field.
8+ years in systems engineering or hardware development with strong mechanical and electrical engineering background.
3+ years in leadership roles within regulated industries (medical devices preferred).
Strong understanding of mechanical and electrical design principles.
Expertise in mechanical design (CAD, tolerance analysis, materials) and electrical design (schematics, PCB layout, power systems).
Expertise in system architecture, integration, and lifecycle management.
Proven track record in medical device development or other regulated industries.
Experience with surgical navigation or imaging systems and familiarity with robotics, sensors, and real-time control systems are preferred
Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance.
Knowledge of risk management and regulatory submissions
Excellent leadership, communication, ability to lead cross-functional teams, and project management skills.
Physical Demands:
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$95k-117k yearly est. Auto-Apply 52d ago
NGS Sales Specialist
Integra Biosciences Corp 4.5
Boston, MA job
Full-time Description
Join the Future of Genomics with INTEGRA Biosciences! At INTEGRA Biosciences Corporation, we're redefining innovation in liquid handling solutions for the medical diagnostics, pharmaceutical, biotech, and food industries. Our cutting-edge technologies empower scientists and researchers to push the boundaries of discovery-and we want you to be part of that journey.
About the Role: NGS Sales Specialist
Are you passionate about genomics and driven by results? As an NGS (Next Generation Sequencing) Sales Specialist, you'll be at the forefront of advancing genomic research and clinical diagnostics. This isn't just a sales role-it's an opportunity to make a real impact in science and healthcare.
In this dynamic position, you will:
Drive Growth: Build strong relationships and deliver strategic solutions to clients in genomics, biotech, and diagnostics.
Showcase Innovation: Lead product demonstrations, installations, and training sessions that inspire confidence and excitement.
Be the Expert: Provide hands-on support and initial troubleshooting in the field, ensuring customers succeed from day one.
Shape the Future: Gather customer insights and collaborate with product teams to influence next-generation solutions.
Who Thrives Here?
Someone who combines deep knowledge of NGS technologies with exceptional communication and sales skills. If you're a natural connector, a problem-solver, and passionate about helping scientists achieve breakthroughs, this role is for you.
What You'll Do:
Drive sales growth in select locations by executing strategic plans and expanding market share.
Identify and develop opportunities through networking, events, campaigns, and direct outreach.
Build strong relationships with researchers, lab directors, and key decision-makers.
Deliver impactful presentations, demos, and training to showcase NGS solutions.
Manage the full sales cycle and maintain accurate CRM records.
Provide hands-on support for installations, troubleshooting, and post-sales service.
Collaborate with internal teams to enhance customer experience and influence product development.
Stay ahead of NGS trends and share insights to guide innovation and strategy.
What We're Looking For:
Education: Bachelor's degree in molecular biology or related field (MS/PhD preferred).
Experience: Minimum of 3 to 5 years with molecular biology techniques and NGS applications.
Strong technical knowledge of NGS workflows and data interpretation.
Proven sales or commercial experience in Life Sciences (preferred).
Excellent communication, presentation, and time management skills.
Self-driven, collaborative, and able to work independently.
Willing to travel extensively (50-75%, including overnight stays).
Location: Territory is primarily Greater Boston, plus travel to the San Francisco Bay area. Initially requires 3 days per week in our Hudson, NH office for completion of training and the start-up process.
This is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. The company reserves the right to revise the job description at any time. The employee must be able to perform the primary functions of the position satisfactorily and that, if requested, reasonable accommodations may be made to enable employees with disabilities to perform the primary functions of their job, absent undue hardship.
INTEGRA Biosciences believes that diversity is a competitive advantage and that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunities regardless of sex, race, creed, color, gender identity or expression, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, body size or shape, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
Salary Description First Year OTE: $150K-$175K (Salary + Commission)
$150k-175k yearly 22d ago
Certified Nursing Assistant/ Home Health Aide/Companion
Integra Seating 4.5
East Longmeadow, MA job
Compensation: $17-$18/ hour
Create your own schedule.
Start immediately upon hire.
Free trainings.
Responsibilities:
Assist clients with activities of daily living, such as bathing, dressing, and grooming.
Provide basic personal care to elderly individuals.
Assist with mobility, transferring and positioning of clients as needed.
Collaborate with clients, families, and healthcare providers to develop and implement care plans.
Benefits
Vacation Time.
Weekly Pay.
Ability to work flexible hours
Requirements:
Must have experience.
Available to work weekends and holidays.
Strong communication and interpersonal skills
Ability to follow care plans and provide high quality care to clients.
*Ability to work independently and as part of a team. We are an equal opportunity employer and prohibit discrimination/harassment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
#INDIHH
$17-18 hourly Auto-Apply 60d+ ago
Global Lead - Medical Affairs, Gastroenterology
Olympus Corporation of The Americas 4.6
Olympus Corporation of The Americas job in Westborough, MA
**Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE; PENNSYLVANIA, CENTER VALLEY** **Workplace Flexibility: Remote** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. _** **_ _** Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
**Patient Focus, Integrity, Innovation, Impact and Empathy.**
Learn more about Life at Olympus: ************************************** .
**Job Description**
The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business. Fundamental competencies for this role include: 1.) Gastroenterology disease state, procedural, clinical, and technological market knowledge & experience, 2.) Comprehensive medical affairs proficiencies (e.g., practice insights, care delivery, intended use, clinical impact, and intended therapeutic benefit) spanning from ideation to execution across the product lifecycle, 3.) Capabilities in clinical integration of current and future gastroenterology diagnostic/therapeutic technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes. The GLMAG is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The intended purpose of this role is to support the Gastroenterology global leadership team as an applied medicine expert for medical strategy development and to champion the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement ("hands on mentality"), together with a personality of being a team player, humble and inquisitive, along with servant leadership skills and the ability to influence across matrixed internal & external environments.
**Job Duties**
+ Medical Strategy: Provide expert medical and clinical insights to inform the effective development of the Gastroenterology medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives. Medical Affairs: This GLMAG is an applied medicine subject matter expert within the Gastroenterology therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development (Initial Conceptualization, Product Development, Launch Excellence, Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.
+ Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit). Clinical Evaluation: The GLMAG will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance.
+ Clinical Care Integration: Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric.
+ HEMA/HEOR: The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner.
+ Therapeutic Area Expertise: Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements.
+ Scientific Platform: Provide critical input for the patient care pathway, as well as the Scientific Communication Strategy and Publication Strategy. Responsibilities also include supporting responses to Medical Information Requests (MIRs).
+ MSA Strategy: Responsible for advocating the Gastroenterology business' unique needs to be incorporated into the MSA strategy as well as operationally through infra-structure advancements, SOPs, best practices, trainings, and work instructions over a 3-5-year time horizon.
+ Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations.
+ GI Leadership Team: Serve as a member of the GI Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Gastroenterology global team is expected.
**Job Qualifications**
**Required:**
+ Medical Doctor (MD) degree, with demonstrated independent clinical practice experience Gastroenterology Fellowship Trained Board Certification.
+ Minimum of 10-12 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
+ Vitality and scheduling flexibility to commit to a global schedule navigating multiple time zones with extended hours into the early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC+1, and Japan Standard Time: UTC+9).
+ Other Considerations (travel/hours availability, etc.): Domestic and international travel 40-50%, including weekend and evening travel as needed.
**Preferred:**
+ Additional advanced degrees: PhD, MS, MBA, or MPH desired.
+ Active participation in a Maintenance of Certification (MOC) program.
+ Active medical license.
+ Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
+ Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
+ A track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
+ Ability to understand current evolving environmental and market access issues.
+ Success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
+ Ability to think strategically, critically assess and synthesize complicated data and scientific information.
+ Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
+ Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
+ Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
**Why join Olympus?**
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
**Equitable Offerings you can count on:**
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center**
**Connected Culture you can embrace:**
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
**Are you ready to be a part of our team?**
Learn more about our benefits and incentives: **************************************/benefits-perks .
The anticipated base pay range for this full-time position is $205,189.00 - $328,302.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ********************** .
**You Belong at Olympus**
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
**_Applicants Requesting Accommodations:_** Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
**Let's realize your potential, together.**
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
$54k-86k yearly est. 60d+ ago
Staff Systems Engineer
Olympus Corporation of The Americas 4.6
Olympus Corporation of The Americas job in Westborough, MA
**Working Location: MASSACHUSETTS, WESTBOROUGH** **Workplace Flexibility: Hybrid** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. _** **_ _** Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
**Patient Focus, Integrity, Innovation, Impact and Empathy.**
Learn more about Life at Olympus: ************************************** .
**Job Description**
The Staff Systems Engineer leads and/or supports all Systems Engineering aspects on new product developmentefforts within the Olympus Surgical Technologies of America (OSTA) organization. Their primary focus shall be NPDprojects and the impacts that they have on the system deliverables.
The major responsibilities of the position areperforming and overseeing others perform activities such as defining system requirements, Sub-system requirementsand software requirements and the associated specifications, making system architecture decisions, outlining designinputs, product design implementation, verification testing and supporting design validation studies.
The ideal candidateis a hands-on technical leader with a strong systems design and integration background. (Knowledge of HW, SW andsystem integration) The Staff Systems Engineer is a subject matter expert (SME) and provides project and engineeringleadership in all phases of complex med-device development, as well as ensures compliance to applicable DesignControls, Product Security, and Cybersecurity policies. (IEC62304, IEC81001-5-1, IEC62366, etc.
The individual shallserve as a core team member on PRP/NPD projects.
The Staff Systems Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk,reliability and User Needs into consideration. She / He must fully understand medical device design controlrequirements, have experience leading technical development efforts, and be effective at communicating advancementsand issues to all levels of the organization.
**Job Duties**
+ Provide project and technical leadership as it relates to Systems to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
+ Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers.
+ Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
+ Work closely with Marketing in collection of user needs/feedback on product requirements and concepts.
+ Lead the requirements development and management process, incorporating risk management elements as required.
+ Provide leadership on detailed design, requirements, architecture and data analysis.
+ Experienced in developing User and Product Requirements.
+ Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements andapplicable standards.
+ Capable of effectively communicating with Core Team and Extended Team Members, while ensuring all R&D deliverables arecompleted with a high degree of quality, and attention to detail.
+ Collaborates on the development of the technical development schedule and monitors.
+ Ensure compliance to product security and cyber security policies, and support efforts to author local SOP's to ensure compliance. (IEC81001-5-1, IEC62304)
+ Support the optimization of design control elements to comply with medical device regulations.
+ Implement product design with the intention of optimizing design for manufacturability and testability.
+ Consider Cost of Goods and lifecycle when selecting components for device designs.
+ Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protectengineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
+ Establish and maintain detailed project plans, defi ne risks and recommend contingency plans as required.
+ Provide support of Risk Management activities, working with Design Assurance.
+ Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualifi cation activities.
+ Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed incompliance to the methodologies of EN 62304.
+ Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customersand the sales force.
+ Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.
+ Experienced in providing technical updates to systems leadership, and/or to an R&D Core Team Member, through weeklydiscussions and monthly updates.
+ Capable of prioritizing and organizing work/eff orts based on project priorities.
+ Experienced in supporting robust design analysis, such as tolerance stack-ups, edge of failure testing, high/low specifi cationevaluations, risk analysis, and statistical evaluations as necessary to ensure performance and quality.
+ Proactively ideates and leads technical risk reduction activities and contingency planning.
+ Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.
+ Manages, directs, and supports suppliers involved in product development and ongoing production, including external designand development partners.
**Job Quali**
**Required:**
+ Bachelor's degree in Mechanical Engineering or similar.
+ Minimum years of related experience: 9 years with BS, 8 years with MS, 5 with PhD.
+ Competency in leading medical device technical development efforts, through all phases of product development, is required.
+ Experience developing disposable medical devices required.
+ Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and internationalrequirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.
+ Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.
+ Self-motivated, engaged, and productive.
+ Proficient in the creation and critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is required.
+ Knowledge of common manufacturing methods, such as; injection molding and molded part design, extrusion, adhesives, ultrasonic welding, etc., as well as experience designing/developing products employing common medical device polymers is required.
+ Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking. Capable of providing problem solving guidance to other engineers.
+ Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations.
+ Must be able to envision design failure modes, plan for robust design assurance testing, and proactively implement contingency plans as necessary.
+ Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred).
+ Must be able to collaborate eff ectively with others, work well within cross-functional teams and across multiple sites, as applicable.
+ Must be able to drive for results.
+ Must be able to communicate effectively at all levels, both verbally and in writing.
+ Strong presentation skills and the ability to influence.
+ Able to predict and manage the expectations of project stakeholders
+ Inspires and motivates others and provides work direction.
+ A positive "Can Do" attitude.
**Preferred:**
+ Experience developing products through a Phase Gate process as a Core Team member is highly preferred.
+ Experience and or working knowledge of developing capital equipment is desired.
+ Working knowledge of Solidworks is a plus.
**Why join Olympus?**
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
**Equitable Offerings you can count on:**
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center**
**Connected Culture you can embrace:**
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
**Are you ready to be a part of our team?**
Learn more about our benefits and incentives: **************************************/benefits-perks .
The anticipated base pay range for this full-time position in this location is $119,670.00 - $167,538.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ********************** .
**You Belong at Olympus**
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
**_Applicants Requesting Accommodations:_** Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
**Let's realize your potential, together.**
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development
$119.7k-167.5k yearly 60d+ ago
Neurophysiologist (Boston, MA)
Globus Medical 4.5
Massachusetts job
NuVasive Clinical Services, a subsidiary of Globus Medical Inc., is a leading provider of intraoperative neuromonitoring (IOM) services to surgeons and healthcare facilities. IOM technology gives those in the operating room real-time insight into the nervous system, which can help surgeons reduce surgical risk by providing critical information and alerts throughout the procedure.
Position Summary:
As a Neurophysiologist at NuVasive Clinical Services, you'll provide intraoperative neuromonitoring during surgery by monitoring the patient's nervous system. A high standard of patient care is essential to our team. This is a great opportunity for you to work with our top surgeons and other medical professionals in a team environment and play a vital role in the operating room every day. As a member of our team, you will also support NuVasive technological innovations. NuVasive provides comprehensive training, continuing education, and numerous opportunities for career development. Please note this is a field-based role.
Essential Functions:
Obtains a detailed medical history on the patient and consults with the surgeon regarding patient structures at risk and modalities to be monitored
Communicates monitoring information to the surgeon and the surgical team throughout the case
Displays and labels waveforms for marking, measuring and calculating information such as latencies, amplitudes and conduction times following established guidelines and protocols
Identifies appropriate protocols and performs troubleshooting techniques to assure accurate data collection
Completes all required documentation and accurately prepares all IOM logs, files, and timely file uploads
Maintains all neuromonitoring equipment and conduct required maintenance checks
Performs other duties as assigned
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
Typically requires a Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
Certified in Neurophysiologic Intraoperative Monitoring (CNIM)
Knowledge of Intraoperative neurophysiological monitoring (IONM) and/or human anatomy & physiology and/or technical troubleshooting preferred
Operating Room (OR) experience preferred
Strong time management & organizational skills, and ability to manage competing demands, frequent change, delays and/or unexpected events in scheduling and in the operating room on a daily basis
Effective communication skills and proven ability to collaborate in a team-oriented setting including communication in English with surgeons and surgical staff
Ability to handle the demands of regular travel
Be qualified for and maintain privileges at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including COVID-19 vaccine, as applicable)
Be eligible for medical malpractice insurance coverage at standard rates, which insurance shall be provided by the Company
Maintain the CNIM status
Travel and/or Physical Demands:
Able to travel up to 25%
Ability to transport and set up equipment totaling 50lbs in a timely fashion in the operating room including IONM system, laptop, and supplies
Ability to bend over to perform certain duties, stand for several periods of time, visual and auditory skills, manual dexterity, wear gloves, masks, gowns, and goggles for extended periods of time
Requires a valid driver's license and transportation with the ability to transport medical equipment in the country of operation
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$78k-92k yearly est. Auto-Apply 60d+ ago
PRODUCT MANAGER, IMAGING
Globus Medical Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
We are seeking a highly motivated Product Manager to drive both upstream and downstream activities across our Excelsius Imaging technology platforms. This role is ideal for a strategic thinker who thrives in a cross-functional environment and is passionate about improving patient outcomes through advanced clinical solutions. This role spans both upstream and downstream responsibilities, with a strong customer-facing component that includes business planning, sales enablement, clinical education, and intraoperative support. You will collaborate closely with R&D, marketing, sales, education, and field support teams to ensure successful product lifecycle management and market adoption.
Essential Functions:
* Collaborates with management to establish strategic plans and objectives
* Conducts market analysis to identify opportunities for new products and line extensions
* Develops pre-clinical and clinical data supporting product innovation
* Creates and manages project plans with engineering counterparts
* Develops marketing plans for new product introductions
* Creates sales tools and training collateral (technique guides, brochures, sales binders)
* Monitors product performance via revenue, adoption, and customer feedback
* Gathers post-launch insights from end users and field teams to guide future iterations
* Supports the sales team with product positioning, demos, and value messaging
* Delivers clinical education to surgeons, OR staff, and sales representatives
* Serves as the voice of the customer, translating clinical feedback into actionable improvements
* Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
* Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
* Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
* Bachelor's Degree with 3+ years of relevant experience
* Experience in medical devices or healthcare preferred
* Strong project management and communication skills
* Highly organized and able to prioritize tasks/initiatives with support from manager and team
* Familiarity with product lifecycle management and regulatory documentation
* Ability to travel up to 20%
Physical Demands:
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
* Required to sit; climb or balance; and stoop, kneel, crouch or crawl
* Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
* Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
* Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
* Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
* Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
* Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$81k-102k yearly est. 60d+ ago
Materials Expeditor
Globus Medical, Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
**Position Summary:**
The Material Expeditor compiles and maintains material and parts inventory and status information to expedite movement of material and parts to production areas. This position requires the individual to be a team player with the ability to function well in a challenging and fast paced environment.
**Essential Functions:**
- Locating and distributing materials to specified production areas, manually or using handcart, hand truck, or forklift
- Examining material received, verifying parts numbers, checking discrepancies such as damaged or unmarked parts, and assembling of material for kits
- Comparing Production Order specifications to material used at workstations to verify appropriate batch assignment
- Working with supervision and the Production Coordinator Manager to resolve problems with product flow through Inspection
- Fulfilling requests for materials and supporting materials audits
- Performing inventory transactions using business system
- Using component serialization/marking
- Maintaining a clean and organized workspace
- Assisting manufacturing and shipping personnel as needed to meet production and shipping schedules
- Working closely with other Operations departments
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
_Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
**Qualifications:**
- High school Diploma or equivalent
- Must be able to lift up to 80lbs
- Ability to use a pallet jack
- Familiarity of Windows & Microsoft Office suites
- Excellent oral and written communication skills
- Ability to work with a high degree of organizational and technical competence
**Physical Demands:**
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
"
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$47k-56k yearly est. 34d ago
Principal Engineer, Design Quality - Software Job Details | Olympus Corporation of the Americas
Olympus 4.6
Olympus job in Westborough, MA or remote
Workplace Flexibility: Field For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: ***************************************
Job Description
This role provides professional expertise for Software quality and best practices in SW design, development, release, and support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, ISO 81001-2, ISO 81001-5-1, and AAMI TIR34971.
This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation and proof of concept. This individual must work with product management, business units, engineering product owners and software architects to define feasible product requirements. This individual is responsible for review and approval of documentation deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA, PMDA, and EU-MDR.
Job Duties
* Advise SW development teams on Software development processes and practices (SiMD/SaMD/Health SW/Cloud). Advise SW development teams on architecture in the context of regulatory impact, safety, security and best practices.
* Investigate and implement harmonization of SW processes across different Olympus legal entities.
* Advise Olympus as a Subject Matter expert on regulations around health software development, and software for medical devices.
* Collaborate on the update of SDLC and operations processes and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices.
* Collaborate on the update of SDLC and operations processes and activities for the inclusion of security-by-design and privacy-by-design in SW development.
* Collaborate with development teams on applying Agile development practices for continuous rapid product delivery while maintaining compliance and quality.
* Provide project management oversight for QMS integration, Quality plans, process updates, and training.
* Represent Olympus's SW development QMS during inspections and audits.
* Perform capability audits of software projects.
* Establish and monitor performance metrics for SW development activities.
* Support the establishment of a response framework for queries and audit findings related to the SDLC.
* Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable.
* Support post-market surveillance operations including complaint monitoring and metrics. NC, CAPA, HHA, and FCA for software related activities.
Job Qualifications
Required:
* Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field. An Advanced degree such as an MS or PhD is preferred.
* Minimum of 9 years of experience in the field of software development, software testing, or systems engineering, or minimum of 8 years for advanced degree.
* Minimum of 6 years of experience in a medical device setting.
* Experience in the application of relevant standards to medical device software and non-medical device health software development, including Software-as-a-Service.
* Experience in project management. Experience in interacting with Regulatory Authorities is preferred.
* Working knowledge in the application of ML/AI to Health SW and medical devices.
* Experience in working across national and cultural boundaries.
* Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a collaborative, coaching, mentoring and/or influencing capacity.
* Strong teamwork and communication skills to work effectively on cross-functional project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.
* Independent organizational and time management skills is required.
* Strong verbal and written communication skills in English; German and/or Japanese is a plus.
* Will work with global teams; availability will include working across the associated time zones; some flexibility in work hours will be expected.
* Travel up to 15% of the time. Candidate will be able to work from home on a regular basis.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: ******************************************************
The anticipated base pay range for this full-time position working at this location is $119,670.00 - $167,538.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ***********************
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
$119.7k-167.5k yearly 15d ago
Global Lead - Medical Affairs, Gastroenterology Job Details | Olympus Corporation of the Americas
Olympus 4.6
Olympus job in Westborough, MA
Workplace Flexibility: Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: ***************************************
Job Description
The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business. Fundamental competencies for this role include: 1.) Gastroenterology disease state, procedural, clinical, and technological market knowledge & experience, 2.) Comprehensive medical affairs proficiencies (e.g., practice insights, care delivery, intended use, clinical impact, and intended therapeutic benefit) spanning from ideation to execution across the product lifecycle, 3.) Capabilities in clinical integration of current and future gastroenterology diagnostic/therapeutic technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes. The GLMAG is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The intended purpose of this role is to support the Gastroenterology global leadership team as an applied medicine expert for medical strategy development and to champion the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement ("hands on mentality"), together with a personality of being a team player, humble and inquisitive, along with servant leadership skills and the ability to influence across matrixed internal & external environments.
Job Duties
* Medical Strategy: Provide expert medical and clinical insights to inform the effective development of the Gastroenterology medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives. Medical Affairs: This GLMAG is an applied medicine subject matter expert within the Gastroenterology therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development (Initial Conceptualization, Product Development, Launch Excellence, Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.
* Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit). Clinical Evaluation: The GLMAG will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance.
* Clinical Care Integration: Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric.
* HEMA/HEOR: The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner.
* Therapeutic Area Expertise: Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements.
* Scientific Platform: Provide critical input for the patient care pathway, as well as the Scientific Communication Strategy and Publication Strategy. Responsibilities also include supporting responses to Medical Information Requests (MIRs).
* MSA Strategy: Responsible for advocating the Gastroenterology business' unique needs to be incorporated into the MSA strategy as well as operationally through infra-structure advancements, SOPs, best practices, trainings, and work instructions over a 3-5-year time horizon.
* Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations.
* GI Leadership Team: Serve as a member of the GI Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Gastroenterology global team is expected.
Job Qualifications
Required:
* Medical Doctor (MD) degree, with demonstrated independent clinical practice experience Gastroenterology Fellowship Trained Board Certification.
* Minimum of 10-12 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
* Vitality and scheduling flexibility to commit to a global schedule navigating multiple time zones with extended hours into the early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC+1, and Japan Standard Time: UTC+9).
* Other Considerations (travel/hours availability, etc.): Domestic and international travel 40-50%, including weekend and evening travel as needed.
Preferred:
* Additional advanced degrees: PhD, MS, MBA, or MPH desired.
* Active participation in a Maintenance of Certification (MOC) program.
* Active medical license.
* Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
* Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
* A track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
* Ability to understand current evolving environmental and market access issues.
* Success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
* Ability to think strategically, critically assess and synthesize complicated data and scientific information.
* Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
* Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
* Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
* Competitive salaries, annual bonus and 401(k)* with company match
* Comprehensive medical, dental, vision coverage effective on start date
* 24/7 Employee Assistance Program
* Free live and on-demand Wellbeing Programs
* Generous Paid Vacation and Sick Time
* Paid Parental Leave and Adoption Assistance*
* 12 Paid Holidays
* On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
* Work-life integrated culture that supports an employee centric mindset
* Offers onsite, hybrid and field work environments
* Paid volunteering and charitable donation/match programs
* Employee Resource Groups
* Dedicated Training Resources and Learning & Development Programs
* Paid Educational Assistance
* US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: ******************************************************
The anticipated base pay range for this full-time position is $205,189.00 - $328,302.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ***********************
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
$45k-80k yearly est. 60d+ ago
Sr Software Engineer
Globus Medical, Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
**Position Summary:**
The Senior Software Engineer will be responsible for major software modules for our Robotics products. The Robotics team is responsible for tracking robot end effectors and other surgical apparatus in the operating room as well as developing novel sensors and displays. This position will be hands-on, and the individual must be capable of creative and systematic product development with minimum supervision.
**Essential Functions:**
+ Develop prototypes, proofs of concept in addition to production-quality solutions
+ Ensure efficient performance and scalability of solutions
+ Contribute to design, testing and documentation of software solutions
+ Occasionally support manufacturing, internal testing, and external customers (sustaining)
+ Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
+ Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
+ Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
_Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
**Qualifications:**
+ Bachelor's degree in computer science or relevant Engineering discipline
+ Minimum of 5 years of C++ experience; Qt framework, python, and/or Matlab experience
+ Strong knowledge of Git, Jira and Confluence tools
+ Must have experience in one of the following
+ Surgical navigation technologies
+ Image Registration
+ Image Processing
+ Robotics
+ Experience in object-oriented analysis and design
+ Software architecture and experience working with a team
+ Software development processes (including source control)
+ Experience with multi-threading and the Windows OS
+ Ability to work independently as well as a key contributor in small teams
+ Excellent oral, written, and graphical communication skills
**Physical Demands** **:**
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
+ Required to sit; climb or balance; and stoop, kneel, crouch or crawl
+ Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
+ Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$87k-106k yearly est. 43d ago
Regulatory Affairs Program Manager, Digital Health
Olympus Corporation of The Americas 4.6
Olympus Corporation of The Americas job in Westborough, MA
**Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY** **Workplace Flexibility: Remote** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. _** **_ _**
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
**Patient Focus, Integrity, Innovation, Impact and Empathy.**
Learn more about Life at Olympus: ************************************** .
**Job Description**
This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a global, high-growth area focused on how digital technologies can help transform current and future products.
This individual will play a key role in establishing and assessing regulatory strategies and requirements for digital health products and solutions, ensuring compliance with global medical device regulations. As part of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will work closely with the DU's development teams to drive digital transformation in the medical technology space. This role involves researching, recommending, and implementing regulatory best practices, contributing to both the strategic and operational functions of the Digital Unit.
**Job Duties**
+ Develop and implement regulatory strategies for digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies.
+ Provide regulatory guidance, compliance risk assessment, and strategic input to digital product development and lifecycle management.
+ Ensure that digital health products, services, and documentation comply with applicable global regulations (e.g., IEC 82340-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, Cybersecurity regulations, and relevant consumer protection laws).
+ Support partnership initiatives to strengthen the Olympus Digital Health portfolio through well selected third party collaborations with third-party providers, ensuring regulatory due diligence in vendor and technology selection.
+ Oversee and support regulatory submissions and compliance filings where applicable (e.g., AI risk classification documentation, cybersecurity certifications, and voluntary compliance frameworks).
+ Support responses to inquiries from regulatory authorities, auditors, or privacy/cybersecurity oversight bodies, and ensure appropriate documentation is maintained for inspections or audits.
+ Monitor evolving regulatory landscapes across multiple regions (U.S., EU, Japan, other APAC markets), staying current on emerging standards and frameworks for AI, digital health software, cybersecurity, and data privacy, and translate these changes into actionable strategies.
+ Assess the impact of regulatory changes on Olympus' digital health initiatives and collaborate with development, privacy, and business stakeholders to adapt strategies and maintain compliance.
+ Serve as a liaison between Olympus RA teams, digital product development teams, quality assurance, privacy, cybersecurity, and business units, fostering alignment across functions.
+ Represent Olympus in relevant digital health and regulatory industry associations, contributing Olympus' perspective and staying connected to external developments.
+ Develop, implement, and maintain standard operating procedures (SOPs), compliance frameworks, and internal regulatory guidance specific to non-medical device digital health initiatives.
+ Design and deliver regular training programs to ensure employees understand and follow best practices in compliance, regulatory considerations, and ethical use of digital health technologies.
**Job Qualifications**
**Required:**
+ BS or comparable required.
+ Minimum of 10 years' experience in Regulatory Affairs, ideally within the medical device or digital health industries.
+ Minimum of 3 years focused on software-driven health technologies.
+ Experience with regulatory compliance for digital health software not classified as medical devices, including AI-enabled consumer health platforms, and connected technologies.
+ Expertise in digital health regulatory affairs, with knowledge of relevant frameworks and guidance outside medical device pathways (e.g., IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, Cybersecurity regulations, and relevant consumer protection laws).
+ Strong track record of leading regulatory strategy for digital health solutions in cross-functional environments, including product development, data science, cybersecurity, and business leadership teams.
+ Demonstrated knowledge of data protection, cybersecurity, and digital trust frameworks, including NIST Cybersecurity Framework, ISO/IEC 27001, and emerging AI ethics guidelines.
+ Experience with digital product compliance documentation (e.g., data protection impact assessments, AI risk classification reports, cybersecurity certifications) and voluntary compliance schemes.
+ Experience working in a global matrix environment and managing interactions with regulators, privacy authorities, and standards organizations.Skilled in working within regulated software development environments (Agile, DevOps) to ensure compliance requirements are integrated into sprint planning and delivery.
+ Strong ability to align digital, business, and R&D leadership on global regulatory expectations, balancing compliance with innovation.
+ Strong problem-solving skills to ensure both compliance and agility in product development Mindset & Behaviours are upheld.
+ Demonstrated ability to influence colleagues without direct managerial responsibility and build strong collaborative relationships within the organization.
+ Excellent communication and stakeholder management skills to facilitate collaboration across teams and external partners.
+ Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.
+ Passion to challenge the status quo and find new strategic directions - embraces change.
+ Comfortable pushing back on multiple parties at the same time.
+ Excellent writing and verbal skills.
+ Travel on occasion, but not more than 10 %.
**Preferred:**
+ MS preferred.
+ Strong understanding or hands-on experience in software development and cloud technologies; experience with enterprise software and modern software engineering practices is desirable.
+ Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a Medical Device highly desirable.
**Why join Olympus?**
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
**Equitable Offerings you can count on:**
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center**
**Connected Culture you can embrace:**
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
**Are you ready to be a part of our team?**
Learn more about our benefits and incentives: **************************************/benefits-perks .
The anticipated base pay range for this full-time position is $104,061.00 - $145,685.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit ********************** .
**You Belong at Olympus**
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
**_Applicants Requesting Accommodations:_** Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (***************.
**Let's realize your potential, together.**
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
$104.1k-145.7k yearly 60d+ ago
Staff Electrical Engineer
Globus Medical, Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
**Position Summary:**
Our rapidly growing medical robotics division is searching for enthusiastic electrical engineers wanting to make a difference. Our engineers develop medical robots by working with top surgeons and a cross-functional engineering team. The Senior Electrical Engineer will be part of a team responsible for designing, implementing, and sustaining electrical designs. The position will be a hands-on one with the individual capable of creative and systematic product development with minimum supervision.
**Essential Functions:**
+ Designs, develops, and debugs FPGA electrical circuits and hardware based on requirements
+ Manages component selection, schematics, and layouts in Altium
+ Interfaces with PCB designers to complete circuit board layouts and documentation packages
+ Develops test fixtures and procedures to evaluate hardware
+ Maintains compliance with industry standards such as IEC 60601
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
+ Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
+ Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
_Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions_ .
**Qualifications:**
+ Bachelor's Degree with a minimum of 8+ years of electrical engineering experience or Master's degree with a minimum of 6+ years of experience
+ Experience with FPGA
+ Familiarity with common communication interfaces including USB, Ethernet, MIPI, SPI, I2C, LVDS, etc
+ Familiarity with image sensors and ultrasound transducers
+ Experience with PCB development including schematic, layout, and debugging
+ Experience with designing and testing for EMC and EMI
+ Experience with IEC 60601 along with NRTL testing
+ Experience in analog and digital circuit design including signal processing, a/d, d/a, power, and firmware design in C and Verilog
+ Experience with schematic capture software such as Altium
+ Experience with circuit modelling software such as PSpice
+ Proficient with electrical test equipment; oscilloscopes, logic analyzers, etc.
+ Proficient in the use of Microsoft Office applications
+ Ability to travel up to 10% of the time
**Physical Demands:**
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
+ Required to sit; climb or balance; and stoop, kneel, crouch or crawl
+ Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
+ Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
$99k-122k yearly est. 60d+ ago
Co-Op
Globus Medical, Inc. 4.5
Methuen Town, MA job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Our Robotics division is seeking an enthusiastic mechanical engineering student wanting to get hands-on and make a difference. As a co-op you will be a member of the mechanical team and responsible for designing, building and testing prototypes. You will drive the execution of your specific project, and a team of electrical, mechanical, and software engineering experts will be available to mentor and support you along the way.
**Position Summary:**
The Mechanical Engineer Co-Op will be responsible for assisting the Product Development team with design and development of medical devices, as well as supporting sustaining engineering activities for launched products in the Trauma Portfolio.
**Essential Functions:**
+ Designing and developing instruments and implants
+ Using CREO and VISIO software to update CAD models, engineering drawings, and manufacturing procedures
+ Working with in-house prototype shop and outside vendors for rapid prototyping and evaluation
+ Performing design verification and validation activities to ensure designs meet specifications
+ Collaborating with in-house engineers, surgeons, and outside vendors to ensure high quality products
+ Assisting with the creation of project plans and Design history Files (DHF) for each project
+ Partnering with engineers on all aspects of various projects
+ Assisting with marketing and product managers to develop forecasts and market plans
+ Ensures all systems are run according to manufacturer instructions, Safety requirements and guidelines, and SOPs
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
+ Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
_Reasonable accommodations may be made to enable individuals with disabilities to perform these_ essential _functions._
**Qualifications:**
+ Actively pursuing a Bachelor's Degree in Mechanical Engineering or other relevant engineering discipline
+ Proficient in Microsoft Office and Outlook
+ Strong self-starting skills, well organized, detail-oriented and capable of working in a deadline driven environment
+ Ability to work independently with minimal supervision
**Physical Demands:**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
**Our Values** **:**
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ **Customer Focused** : We listen to our customers' needs and respond with a sense of urgency.
+ **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
**Equal Employment Opportunity** **:**
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
**Other Duties** **:**
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Zippia gives an in-depth look into the details of Olympus, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Olympus. The employee data is based on information from people who have self-reported their past or current employments at Olympus. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Olympus. The data presented on this page does not represent the view of Olympus and its employees or that of Zippia.
Olympus may also be known as or be related to Olympus, Olympus America Inc, Olympus America Inc., Olympus Corporation, Olympus Corporation of the Americas and Olympus Latin America, Inc.