Candidate will set up, configure and support internal and/or external networks, develop and maintain all systems applications, security, and network configurations. Troubleshoots network performance issues and creates and maintains a disaster recovery plan. Recommends upgrades, patches, and new applications and equipment. Develops and communicates standards for use, operations, and security of network, personal computers, and data
Responsibilities
Manages and implements upgrades of IT hardware and software systems for both physical and cloud environments.
Maintain policies and procedures related to IT, Cybersecurity, FDA and SOX regulations.
Work with external auditors for ITGC/SOX testing
Designs, specifies, configures, installs, and maintains local area network hardware, software, and telecommunications services including personal computers, system software, software applications, printers, servers, routers, switches, cabling.
Implements policies and procedures related to network hardware and software, acquisition, use, support, security, and backup.
Establishes and maintains network users, user environment, directories, and security.
Maintains disaster recovery procedures.
Maintain contracts and coordinates activities of hardware, software, telecommunications, support, and training vendors.
Works with functional departments to report and resolve software, hardware, and operational problems.
Pay range $90,000-$120,000 per year
The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. Actual base salary pay will be based on a number of factors, including , relevant education, qualifications, certifications, experience, and other job-related factors permitted by law.
Qualifications
Qualifications:
Some travel required
Bachelors Degree
7 years equivalent work experience
Experience in an FDA or SOX regulated environment
US Citizenship
Technical:
Microsoft Windows Environment
Azure Entra
Microsoft Exchange
Microsoft SQL
Cisco Meraki
Excellent Interpersonal and Communication Skills
Strong management skills
Strong Technical Skills
EEO Statement
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at ***************.
$90k-120k yearly Auto-Apply 60d+ ago
Field Installation Project Manager
Hologic 4.4
Marlborough, MA job
Here at Hologic, we are driven by our passion to become the global champion for women's health. As a leading innovator of women's health, we are empowering people to live healthier lives everywhere, every day.
The Installation Project Manager plays a key role in fulfilling our passion by leading the charge to deliver on-time and successful installations of our life-changing devices.
This role will drive the end-to-end capital implementation including project planning, capital product installations, capital upgrades, and room renovation while participating in initiatives resulting in a new streamlined model that enables installation consistency, improved performance, costs, and governance. This is a customer-facing role representing Hologic at the highest standard. This role is highly dynamic, requiring strong critical thinking skills with the ability to think on your feet, deliver results, and build strong relationships. Collaboration and clear communication are crucial.
Essential Duties and Responsibilities
Works with local sales and installation teams as the customer's operational point of contact throughout the pre-install and physical installation phase
Drives high quality and on-time execution of capital shipments through consistent management of our capital orders
Delivers a best-in-class installation project management experience by forming strong relationships with our customers and through reliable project planning
Exhibits ownership and accountability for each step of their capital projects
Collaborates with internal and external partners to ensure installation site readiness through technical and construction requirement reviews, site walk-throughs, call coordination, and anticipation of potential issues
Adaptable to potential issues, changes in project scope, process updates, timelines, and resources
Able to analyze options and offer alternative solutions while balancing the customer and business strategic goals.
Consistently communicates project goals, updates, risks, and changes in a clear and timely manner to all project stakeholders.
Validates customer requested ship and delivery dates with install team members.
Fosters a positive and collaborative environment with teammates and customers.
Qualifications:
Ability to establish, schedule, track and communicate all activities related to the installation of digital mammography imaging products. This includes pre-installation planning and equipment layout, site readiness, equipment delivery, and coordination and communication of FE, Connectivity, and Applications activities. Must be detail oriented and very organized.
Must be able to travel within assigned territory as needed to meet with customers, contractors, and Hologic service personnel. Minimum travel expectation is 30%.
Technical aptitude and fundamental knowledge of mammography and digital mammography in particular desired.
Strong interpersonal skills.
Education:
Associate Degree in a technical or project management discipline. Bachelor's degree preferred. Equivalent blend of education and experience may be considered.
Experience:
2 to 5 years' experience in capital equipment site planning and installation coordination.
Specialized Knowledge:
Architecture as it applies to site planning in capital equipment installation environment. Basic knowledge of standard drafting methods and practices. Fundamental knowledge of electrical requirements and networking terminology.
The annualized base salary range for this role is $81,100 to $126,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency And Third Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Same Posting Description for Internal and External Candidates
$81.1k-126.8k yearly 6d ago
Material Handler
Lemaitre Vascular 4.6
Lemaitre Vascular job in Burlington, MA
Performs the receipt process of all raw materials, returned finished goods, indirect supplies, and various shipments to LeMaitre employees. Handles raw materials product lines, and kits material to work orders, performs daily inventory cycle counts .
Responsibilities
Receive in raw materials and sub-assemblies using the proper procedure, including assigning a lot number and preparing the items for quality inspection.
Receive in indirect supplies, consumables, R&D items and shipments to LeMaitre employees.
Oversee movement of all received items to its proper next destination, including delivery if necessary.
Receive and process customer and international returns, and prepare items for quality inspection.
Receive and process trunk stock, and prepare for quality inspection.
Participate in raw materials and finished goods cycle counting.
Sorts all material upon receipt into pre-kitted quantities for work orders
Kits material for Dept. 1 work orders
Handles material requests from all departments, including manufacturing engineering, R&D, and quality
Participates in proper storage of material
Participates heavily in year-end inventory count; overtime likely in December
Transfers materials between buildings when needed
Backup IFU operator
The pay range for this position is $21 to $24 per hour.
The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. This role may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Qualifications
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Independent Thinking - Candidate must be able to work independently.
Interpersonal Skills - Focuses on solving conflict, not blaming; Listens to others without interrupting; Keeps emotions under control.
Cost Consciousness - Develops and implements cost saving measures; Conserves organizational resources.
Diversity - Shows respect and sensitivity for cultural differences.
Ethics - Treats people with respect; Works with integrity and ethically; upholds organizational values.
Organizational Support - Follows policies and procedures.
Professionalism - Accepts responsibility for own actions.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent.
Dependability - Takes responsibility for own actions.
EEO Statement
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at ***************.
$21-24 hourly Auto-Apply 55d ago
Intern, Graphic/Instructional Designer
Hologic 4.4
Marlborough, MA job
Marlborough, MA, United States **Help Us Shape the Future of Learning: Join Our Global Services Learning & Development Team!** Are you curious about how big companies train their teams to stay sharp and succeed? Our Global Services Learning & Development team is on a mission to empower over 500 Field Service Engineers (and more!) with the tools and knowledge they need to thrive. As a Summer Intern, you'll dive into the world of corporate training, working with experts to create and improve engaging learning experiences. If you're ready to grow your skills and make an impact, keep reading!
**What you'll be up to during your 10-12 week adventure:**
+ Team up with our Instructional Designer to help create online courses and classroom training materials.
+ Keep our learning management system up-to-date by maintaining records and curricula.
+ Review and refresh training content so it's accurate, relevant, and (dare we say) interesting.
+ Collect feedback from learners and instructors to help us make our programs even better.
+ Join team meetings, share your ideas, and help us find smarter ways to do things.
**Who we're hoping to meet:**
+ You can work full-time during the summer (May/June - August/September).
+ You're currently working on your Bachelor's or Master's degree, with at least one semester left after the internship.
+ Your major is in Graphic Design, Communications, Instructional Design, Education, or something similar.
+ You're heading into your junior or senior year, or you're a master's degree candidate.
+ You know how to get your point across, whether you're writing or speaking.
+ You've got some experience with MS Office (Excel, Word, PowerPoint)-bonus points if you've dabbled with LMS platforms, e-learning tools, or design/video editing tools.
+ You notice the little things and keep yourself organized (your planner is probably color-coded).
+ You can roll solo or work as part of a team-flexibility is your middle name!
**Location, pay & other important details:**
+ You can work **onsite** at our **Marlborough, MA** campus. **Heads up** : intern housing, relocation, and housing stipends aren't provided, so you'll need to have your living situation and transportation sorted out.
+ Pay range: $21 - $25 per hour, based on your class standing and operational function.
+ The chance to work with a team that's genuinely invested in your growth.
+ Networking, mentorship, and skill-building opportunities-all designed to help you thrive.
**Take your internship to the next level at Hologic!**
When you join Hologic as a Summer Intern, you're not just clocking in for a job-you're jumping into a global team full of motivated, creative, and dedicated people (basically, your future favorite coworkers). This is your chance to shine, show off what you know, and bring your energy and ideas to projects that make a real difference for people all over the world.
On top of hands-on experience in your field, our College Relations team will hook you up with opportunities to learn about the company, meet leaders, and build the skills you'll need to launch your career. Consider this your backstage pass to the future of healthcare innovation.
**_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._**
\#LI-EK1
$21-25 hourly 39d ago
Medical Science Liaison, Radiology
Hologic 4.4
Marlborough, MA job
United States At Hologic, we're an innovative medical technology organization that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health
What powers our growth across Breast & Skeletal Health, Diagnostics and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
Hologic Breast & Skeletal Health team is seeking a field based Medical Science Liaison (MSL) to join the team.
**Duties & Responsibilities:**
+ Facilitate the exchange of medical and scientific data to a targeted audience including key opinion leaders (KOL's), physicians, and other health care providers regarding Breast and Skeletal Health products via in-person or virtual presentations to increase awareness of technology.
+ Develop content to support peer-to-peer scientific discussions regarding clinical evidence.
+ Support cross functional teams in initiatives such as faculty speaker training and review of promotional and educational scientific materials.
+ Conduct medical and scientific education and support for the field organization.
+ Maintains clinical, scientific, and technical expertise via review of scientific journals, partnership with product and technology experts, and attendance at conferences, technical meetings and symposia.
**Qualifications:**
+ Ability to rapidly acquire knowledge of applicable disease states, clinical trends, and emerging research related to Hologic's Breast and Skeletal Health products and knowledge of the competitive landscape in the breast cancer screening, diagnosis, and treatment space.
+ Ability to work successfully in a team environment, and engage regularly with marketing, clinical affairs, regulatory affairs, legal, sales management, and R&D to understand scientific/clinical information, business strategies, and market dynamics in order to execute the appropriate clinical discussions with customers.
+ Ability to communicate complex messages clearly.
+ Excellent verbal and written communication skills, with experience writing and publishing materials for peer reviewed publications preferred.
+ Advanced scientific analytical skills.
+ Ability to integrate and apply feedback in a professional manner.
**Education/ Experience:**
+ Ph.D. in an applicable scientific discipline, with post-doctoral fellowship training in a biomedical science discipline desired but not required.
+ One to three years clinical, medical or scientific experience within a medical device, biotechnology or pharmaceutical company desired.
+ Oncology, radiology or medical imaging experience, particularly in breast cancer, is preferred.
**Additional Details:**
+ Work is performed in a home office, company office, conference environments and customer sites
+ Position requires ~25-50% travel; may include overnight and weekend travel
The annualized base salary range for this role is $128,700 to $201,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
**Agency and Third Party Recruiter Notice**
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
**Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.**
**\#LI-JM1**
$128.7k-201.4k yearly 48d ago
Corporate Counsel
Lemaitre Vascular 4.6
Lemaitre Vascular job in Burlington, MA
This role, reporting to the Chief Legal Officer, is responsible for providing general corporate legal support to a global, Nasdaq-listed medical device company based in Burlington, Massachusetts. The successful candidate will assist with all legal and compliance matters and interact with all departments within the organization, providing legal service and support for all aspects of LeMaitre's activities.
Responsibilities
Commercial contracting
Corporate compliance (e.g., data privacy, anti-bribery/FCPA, fraud and abuse, healthcare transparency laws)
Marketing legal support
Global subsidiary support
Litigation management and employment
Securities ('34 Act and Section 16 reporting)
Mergers and acquisitions
Corporate governance, financing and other general corporate matters
Legal Counsel support to management in various departments, identifying risks and offering advice and alternatives to mitigate risk
Pay range $180,000-$220,000 per year plus bonus and equity. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.
Qualifications
Education: Juris doctorate required
Functional Experience: Minimum of 6-8 years' experience in general corporate representation. In-house and/or large law firm experience preferred.
Industry Experience: Specific industry experience is not required, though life sciences experience is preferred. General corporate experience is required, and date privacy experience is preferred.
Computer Skills: Proficiency with Word, PowerPoint, Outlook and Excel required.
Travel: Must be able to travel domestically and internationally when needed, though not expected to be frequent.
Schedule: Must be able to work in the office 5 days a week in Burlington, Massachusetts during core business hours.
Language Skills: Fluency in English. Ability to communicate effectively with all levels of the organization verbally and in writing.
EEO Statement
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at ***************.
$180k-220k yearly Auto-Apply 41d ago
Facility Mechanic
Hologic 4.4
Marlborough, MA job
Marlborough, MA, United States The Facility Mechanic will execute facility maintenance service activities to support Hologic's mission and business objectives. This position works as part of our facilities team, providing a broad range of hands-on responsibilities. The ideal candidate demonstrates excellent customer service, the ability to work independently, and a strong work ethic.
**Key Responsibilities:**
+ Perform general repair and maintenance duties, including drywall repair, painting, systems furniture modifications, lamp replacement, small plumbing repairs, and other facility-related tasks.
+ Provide hands-on support for internal and external facility moves.
+ Organize and manage inventory of facility furniture.
+ Provide routine on-call assistance as required.
+ Deliver building maintenance services through preventive maintenance (PM) and work order (WO) programs, maintaining accurate records.
+ Coordinate and support contracted facility services (housekeeping, pest control, HVAC, electrical, etc.).
+ Provide maintenance support across multiple facilities as needed.
+ Assist with workstation reconfiguration requirements.
+ Coordinate and support building maintenance activities with landlord or affiliated contractors (generator, HVAC, compressor, etc.).
+ Organize, inventory, and reorder facility-related safety and maintenance supplies as needed.
+ Comply with all company policies and procedures, including safety regulations, PPE requirements, SOPs, Quality System Regulations, and Good Manufacturing Practices (GMP).
+ Support Environmental, Health, and Safety (EHS) initiatives, including weekly and monthly maintenance tasks.
+ Participate in insurance-required human element procedures, such as fire alarm shutdowns, hot work permits, and sprinkler valve checklists.
**Qualifications:**
+ Strong communication, interpersonal, and organizational skills.
+ Excellent customer service skills for both internal and external customers.
+ Proficiency with Microsoft Office.
+ Ability to prioritize and manage multiple tasks effectively.
+ Basic understanding of facility operations.
+ Ability to work independently and complete assignments with minimal supervision.
+ Ability to occasionally lift up to 70 lbs.
+ Familiarity with FDA-regulated environments.
+ Possess a valid driver's license and reliable transportation.
+ Ability to travel occasionally (less than 5% of the time) to other Hologic office locations, as needed.
**Education & Experience:**
+ High school diploma required.
+ Minimum of 2+ years of maintenance experience, preferably in a regulated environment.
**Training Requirements:**
All employees are required to complete training in relevant policies and procedures based on facility activities and corporate standards.
**So why join Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!
The annualized base salary range for this role is $44,500 - $66,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
$44.5k-66.8k yearly 27d ago
Technical Support Specialist
Hologic 4.4
Marlborough, MA job
United States All around the world people are looking for an answer, a test result, or a procedure that will offer them clarity and a path to a healthier life. By working with Diagnostic products that make a difference globally, your impact can be greater than you have ever imagined. Hologic offers a space for employees to own their passion and feel a sense of purpose each and every day.
Our award-winning **Technical Support** team plays a big role in that mission. They provide phone and email support to both internal and external customers, troubleshooting issues with Hologic's cytology and molecular products.
**Think this role is for you?**
This individual has an ability for troubleshooting issues beyond "computer stuff." In this role, you will be troubleshooting our diagnostics instruments (cytology and molecular), reagents, and operator issues.
You will be offering technical support to internal customers (R&D, Field Service, Quality, Marketing, etc.) and external customers (Lab technicians, hospitals, etc.) via phone and email.
We provide support 24/7, you may be on-call and serve as back-up for technical and application support as needed, including some holidays.
**Key Outcomes:**
+ Provide customers with service and product troubleshooting for cytology and molecular products, including instruments, reagents, and software, via phone and email.
+ Document calls in the CRM system and escalate issues that require further investigation.
+ Authorize return of customer product for investigation.
+ Determine replacement of product as warranted.
**Potential Growth Opportunities:**
+ Represent Technical Support as specialist for designated product(s).
+ Act as liaison to other departments within the division concerning issues related to specific product lines.
+ Serve on product development or support teams. Provide Technical Support team with troubleshooting training and informational updates.
+ Work with Marketing and Service departments at the launch of new products. Reviewing or creating label copy, participate in pre- and post-launch teams.
+ Build relationships with partners and distributors.
+ Writing and reviewing procedures.
+ Provide guidance and coaching to other Technical Support personnel.
**Do you have what it takes?**
+ You are technically inclined, you understand science - DNA, RNA, Cytology, reading the package insert on a medical product doesn't sound like a foreign language to you.
+ You have a customer service mentality, you are patient, have good communication and computer skills and are great at multi-tasking.
+ You are comfortable speaking on the phone and have flexibility in your schedule.
+ We are looking for someone who is eager to start their career in this field and wants to grow within the department.
**Additional qualifications:**
+ Bachelor's degree in biology, Cytotechnology, Medical Laboratory Science, or related field (required).
+ ASCP Cytotechnologist (CT), Medical Technologist (MT) or Clinical Laboratory Scientist (CLS) certification or equivalent (desired).
+ Experience as a Cytology Prep Technician (desired).
+ Experience with cytology, RT PCR, molecular, or virology (desired).
+ Ability to troubleshoot Laboratory Information Systems interfaces and/or network computers (desired).
If you are not sure that you are 100% qualified, but are up for the challenge, we want you to apply!
The annualized base salary range for this role is $71,000 - $106,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
$71k-106k yearly 38d ago
Sr. Electrical Engineer - Product Engineering - Marlborough, MA
Hologic 4.4
Marlborough, MA job
As a Sr. Electrical Engineer, Product Engineering, you'll maintain hardware continuity for our existing portfolio and drive design improvements that elevate quality, performance, and cost efficiency. You'll be a key stakeholder across Regulatory, Quality, Manufacturing, and external suppliers-leading and supporting multiple projects simultaneously. Your expertise will help troubleshoot hardware issues, develop robust verification strategies for design changes, and support the continuous improvement of our systems. This role will be located in Marlborough, MA and we will require 100% onsite presence.
Key Responsibilities:
* Safeguard the lifecycle of existing products by evaluating and managing electrical component End-of-Life (EOL) across multiple PCBs and products.
* Lead troubleshooting efforts for electrical and electro-mechanical systems on field returns, determining root causes and implementing design changes based on quality and risk imperatives.
* Drive hardware design efforts for product line extensions, VIPs (Value Improving Projects), and new features for existing products.
* Develop electrical test fixtures and prototype boards to support testing and design improvements.
* Support manufacturing with process and fixture improvements for critical hardware.
* Collaborate with strategic sourcing partners and suppliers to implement technical cost-saving design changes and solve design challenges.
* Interpret and improve verification methods for electrical components, PCBs, and subsystems to ensure state-of-the-art practices.
* Build and maintain strong collaborative relationships with key internal and external stakeholders.
* Stay current with emerging technologies and processes to fuel ongoing innovation across the portfolio.
Qualifications & Experience:
* Bachelor's or Master's in Electrical Engineering.
* 5+ years' experience in new product development and/or medical device industry (with Bachelor's).
* 3+ years' experience in new product development and/or medical device industry (with Master's).
Skills & Attributes:
* Ability to troubleshoot and root cause failure modes in PCBs and electro-mechanical systems.
* Schematic-level design experience, preferably with Altium toolset.
* Proficiency with electrical test and development equipment (oscilloscopes, LCR meters, logic analyzers, power supplies).
* Foundational knowledge of DFM (Design for Manufacturing) in electrical engineering design.
* Experience with FPGAs, CPLDs, analog and digital circuits, microcontrollers, and power delivery circuitry.
* Experience designing for IEC 60601 safety and EMC compliance.
* Familiarity with embedded systems and ability to collaborate with hardware and software teams.
* Exceptional verbal, written, and presentation communication skills, with the ability to adapt for technical and non-technical audiences.
* Proficient in generating technical documentation, including test protocols, reports, and design descriptions.
Travel:
Ability to travel as necessary, up to 10%.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
LI-#DS1
#onsite
$97.6k-152.7k yearly 35d ago
Vice President of Surgical R&D
Hologic 4.4
Marlborough, MA job
Denver, CO, United States The Vice President, Research & Development, GYN Surgical will be reporting to the Division President. The successful candidate will be accountable to engage a global team and build/execute on the future product development strategy of the division. As a member of the GSS leadership team, the leader will contribute his or her understanding of the business and customers to facilitate the acceleration of the Surgical commercial performance and results with both disposable, reusable and capital devices. The VP, R&D will play a role in defining the business strategy and will be responsible for early-stage research, new product development, and sustainment projects. The VP, R&D will play a key role over the entire product lifecycle, including understanding of existing product performance, reliability, complaints and customer experience, and maintaining a high-quality product portfolio. As Hologic is active on the mergers and acquisitions front, the leader will need to steer key deliverables as it relates to due diligence and integration activities.
**Key Leadership Responsibilities**
+ Lead the teams of Mechanical, Software, Electrical, Systems and PMO, which operate in key strategic areas like GYN Surgical and Specialty Surgery (ie energy) and promote a high-performance and results-driven culture.
+ Attract, develop and retain top talent for the R&D function, while motivating staff to continually improve its performance.
+ Execute on the division's overall vision, shaping its technical strategy, leading all engineering efforts and driving its development execution
+ Partner with Marketing in developing a strong product pipeline and a portfolio of marketed products that are differentiated and provide competitive advantage for Hologic.
+ Formulate and implement the long-term strategy with respect to new, emerging, and disruptive technologies that advance company objectives.
+ Collaborate closely with all functional areas necessary to aggressively advance products from proof of concept through validation and product launch, including Regulatory, Quality, Manufacturing, Finance, Legal, Business Development, Sales & Marketing
+ Work closely with management to effectively identify new intellectual property (IP) initiatives and translate those into new products and/or procedures
+ Monitor and analyze technology and trends that could improve the company's products and performance
+ Lead technical support team, monitor existing product portfolio, collect complaints, and support initiative to improve customer experience.
+ Serve as a member of the leadership team and key advisor to Division President in defining and directing the strategy, key priorities and decisions for business.
+ Directly responsible for the establishing and managing the R&D/Engineering budget
More specifically, the **minimum requirements** set for this role are:
+ Bachelors in Engineering, Mechanical/Electrical or equivalent required
+ PhD in related field strongly preferred
+ 15+ years of global experience in Engineering, Development, or Strategy roles
+ 10+ years of managerial experience, managing people and budgets (P&L's), collaborating and influencing executive level leaders within sales, marketing and other commercial functions
+ Demonstrated success working in an innovative environment and in the development of products and services
+ Experience in setting and scaling the research and development function, with the proven ability to attract, inspire, motivate and retain top tier talent.
**So why join Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
We offer a competitive salary as well as quarterly commission based on sales target.
**Agency and Third Party Recruiter Notice:**
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
$138k-192k yearly est. 60d+ ago
Quality Assurance Engineer 2
Hologic 4.4
Marlborough, MA job
Are you passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer - Product Quality to play a critical role in managing product holds, stop ships, corrections, and field actions. In this role, you'll develop and maintain Quality Management System (QMS) procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. If you're detail-oriented, proactive, and eager to contribute to the continuous improvement of product quality, this is your opportunity to make a meaningful impact in the healthcare industry.
Knowledge:
Strong understanding of Quality Management Systems (QMS) and regulatory requirements, including field action management, product holds, and stop ships.
Familiarity with FDA regulations, ISO 13485 standards, and corrective/removal action processes.
Knowledge of product lifecycle management systems and best practices for tracking quality records.
Expertise in root cause analysis methodologies and corrective action processes.
Skills:
Proven ability to develop, implement, and maintain QMS procedures and work instructions for product holds, stop ships, and corrections/removals.
Strong organizational skills to plan, execute, and monitor field actions, recalls, and corrective actions.
Effective communication skills to liaise with corporate process owners, external vendors, and cross-functional teams.
Technical writing skills for documenting progress, tracking closure of records, and creating training materials.
Ability to conduct complex investigations and provide clarity into root cause findings.
Proficiency in identifying process improvements and recommending enhancements to quality systems.
Experience in providing training, guidance, and ongoing support to ensure proper utilization of quality tools and systems.
Behaviors:
Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements.
Collaborative and team-oriented, building strong partnerships across functions to drive results.
Problem-solving mindset, with a focus on continuous improvement and operational efficiency.
Results-driven, with the ability to manage escalations and adverse trends effectively.
Adaptable and resilient, thriving in a fast-paced, regulated environment.
Experience:
2-4 years in Quality Assurance, Project Management or Customer Service roles in a medical device or related regulated industry.
Hands-on experience with field actions, product holds, stop ship processes, and corrective/removal activities.
Proven track record of supporting QMS initiatives, including integration and process improvements.
Experience conducting complex investigations and implementing corrective actions.
Familiarity with cross-functional collaboration on quality improvement projects.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $78,000-$122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-NT1
$78k-122.1k yearly Auto-Apply 21d ago
Senior Product Quality Engineer
Hologic 4.4
Marlborough, MA job
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply!
Knowledge:
Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management).
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Knowledge of root cause analysis tools and risk-based decision-making processes.
Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility.
Skills:
Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance.
Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations.
Ability to manage and implement design or process changes, including testing, documentation, and change control.
Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes.
Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products.
Behaviors:
Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality.
Experience:
Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required.
5+ years of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
1-3 years of experience with a Master's degree, or 0-1 year with a PhD in a related field.
Experience in an FDA-regulated industry preferred.
Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-NT1
$97.6k-152.7k yearly Auto-Apply 31d ago
Director, Design Assurance
Hologic 4.4
Marlborough, MA job
Newark, DE, United States Louisville, CO, United States Marlborough, MA, United States Are you a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of Design Assurance** to spearhead our Design Assurance organization, supporting new product development and sustaining activities for our Breast and Skeletal Health (BSH) products. This role is crucial in driving sustainable compliance, optimizing QMS processes, and fostering a culture of continuous improvement. We are located in Newark, DE and are open to hybrid presence.
**What You'll Do:**
+ **Strategic Leadership** :
+ Direct the Design Assurance organization to support new product development and sustain activities for BSH products.
+ Ensure the appropriate organizational structure and personnel development to meet divisional strategies and goals.
+ **Team Management** :
+ Lead the BSH Design Assurance team, including managers and Design Assurance engineers.
+ Oversee activities, set goals, manage project resourcing, and provide guidance for product support.
+ Recruit, retain, and manage multiple direct reports, focusing on performance management, employee development, mentoring, and coaching to maximize engagement and productivity.
+ **Quality and Compliance** :
+ Promote awareness and efficacy of design control and risk management procedures/processes.
+ Drive continuous improvements through collaborative relationships with stakeholders.
+ Develop and oversee the application of design controls and risk management while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, and enhancing manufacturability and cost efficiency.
+ **Operational Excellence** :
+ Direct activities, establish goals and objectives, define expected performance, and provide daily support and regular feedback regarding execution.
+ Assess the skillsets, competencies, and organization structure of the Design Assurance function, developing strategies and plans to meet current and future needs.
+ Consult with stakeholders to understand and plan for business strategies and needs.
+ **Guidance and Oversight** :
+ Provide guidance to managers and Design Assurance Engineers on design control compliance requirements, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.
+ Address technical and project-based issues, assisting in the development of solutions and approaches for successful team alignment.
+ **Resource Management** :
+ Participate in resource planning and management for new product development, sustaining product support, and sustaining projects.
+ Collaborate with the divisional program management team, manufacturing sites teams, and design assurance team to ensure projects are clearly scoped, appropriately allocated, and aligned with divisional and company priorities.
+ **Ongoing Support and Improvement** :
+ Participate in ongoing product/project support activities, including sustaining project management, complaint review boards, real-time aging review boards, and design review committees.
+ Monitor the efficacy of design control and risk management processes and competency of personnel, identifying areas for improvement and building consensus on improvement initiatives.
+ Sponsor and coordinate improvements to established procedures and initiate new procedures as needed.
+ **Risk Management and Compliance** :
+ Accountable for risk management within the context of post-market surveillance, ensuring Risk Management files are up to date and Health Risk Assessments are initiated where appropriate.
+ Oversee Health Risk Assessments in evaluating on-market products, ensuring efficient and effective analysis of situations, including problem definition and benefit-risk profile consistency.
+ Promote awareness of design controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams.
**Qualifications:**
+ **Education** :
+ Bachelor's Degree in a technical Engineering field.
+ **Experience** :
+ 12+ years of experience with a Bachelor's Degree or 10+ years with a Master's Degree.
+ Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive.
+ Familiarity with ISO 14970, IEC 60601, IEC 62366, and EN 62304.
+ Experience with managing multi-source demands for project and product support, fostering an effective team environment.
+ Experience with Oracle or Agile is beneficial.
+ **Skills** :
+ Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
+ Thorough knowledge of Root Cause Methodologies, Risk Management, Lean Manufacturing, Kaizen, Kanban, Poke Yoke, and visual factory ideology.
+ Strong working knowledge of verification and validation requirements for regulated products and requirements analysis, including developing testable and measurable specifications.
+ Ability to assess product and project documentation as the principal advocate for compliance and effectively communicate assessments.
+ Proven ability to direct managers, supervisors, and individual contributors with varying experience levels across multiple products and projects.
+ Ability to develop and manage high-performing, motivated, and engaged teams. Familiarity with employee development and mentoring processes.
+ Demonstrates independent decision-making and prioritization, including resolving conflicts.
+ Lean-Six Sigma Green or Black Belt Certification is beneficial.
+ PMP Certification is beneficial.
**So why join Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!
The annualized base salary range for this role is $167,400 - $297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
**Agency and Third-Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
**Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.**
\#LI-Lb2
$167.4k-297.6k yearly 60d+ ago
Scientist 2
Hologic 4.4
Marlborough, MA job
Marlborough, MA, United States **Why Hologic?** Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
**What to expect:**
+ Performs functions which support the operation of the Scientific Product Support laboratory and executes internal, external, and cross-departmental studies for product development, new applications, and failure analysis.
+ Operates sample preparation instrumentation, maintains supplies, completes necessary logs/records, and performs preventive maintenance on laboratory equipment.
+ Must be comfortable in a laboratory environment working with various chemical and biological samples.
+ Committed to high quality standards and timely completion of tasks; punctual
+ Communicates clearly and accurately with others; works cooperatively in teams
+ Organized; capable of multi-tasking
+ Proficient in liquid pipetting and performing chemical dilutions
+ Proficient in Microsoft Office and able to use advance statistical and data analysis software
**What we expect:**
+ Modifies and trains others to safety procedures and may develop engineering controls
+ Develops and writes protocols and reports for moderate/highly complex studies
+ Designs and executes moderately complex experiments to complete larger projects, including standard and factorial (DOE) experiments
+ Completes project documentation following Quality System requirements
+ Adheres to all laboratory and biohazard safety procedures
+ Completes all required trainings on time
+ Provides support for QC activities and may oversee laboratory work or manage individuals
+ Participates in LEAN initiatives
+ Identifies and mitigates external and customer issues
+ Delivers presentations to internal and external groups
+ Collaborates with outside groups on project related issues or studies
+ May write/review papers for publication and contribute to development of intellectual property
+ Analyzes, devises, and recommends methods to resolve problems
+ Identifies new laboratory instrumentation based on project needs
+ Monitors competition of tasks and projects
**Education & Experience:**
+ Bachelor's Degree required
+ 6 years of laboratory experience with Bachelor's Degree
+ 4 years of laboratory experience with Master's Degree
+ 0-2 years of laboratory experience with PhD
+ Hepatitis B vaccination required.
The annualized base salary range for this role is $97,900 to $153,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..
**Agency and Third Party Recruiter Notice:**
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
**_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._**
**_\#LI-PR1_**
**_Must follow all applicable FDA regulations and ISO requirements._**
**_Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)_**
$97.9k-153k yearly 4d ago
Director, Payer Relations
Hologic 4.4
Marlborough, MA job
Marlborough, MA, United States As a leading innovator of women's health, Hologic is empowering people to live healthier lives everywhere, every day. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
Hologic is seeking a Director, Payer Relations within the market access team to drive the payer engagement strategy and execution for our breast surgery portfolio in the United States. This role will be instrumental in optimizing reimbursement pathways, expanding coverage, and ensuring access across various sites of care.
This role will work in close partnership with the broader market access team and will involve cross-functional coordination with teams including Commercial Marketing, Sales, Medical Relations, Health Economics & Outcomes Research, and Government Affairs.
Successful candidates will have experience advocating for coverage and reimbursement with national and regional health plans in the U.S., ideally with a background in medical device, drug, radiopharmaceuticals, radiology or breast surgery. Candidates should possess strong communication skills, as well as an ability to analyze, interpret, and influence complex reimbursement landscapes.
**Duties & Responsibilities**
+ Manage a network of key relationships with health plans across Commercial, Medicare and Medicaid
+ Develop and execute payer strategies to optimize access of target technologies and procedures.
+ Build out materials, tools, and messaging in partnership with internal teams to support payer objectives with medical directors and other key stakeholders
+ Educate key stakeholders on the clinical and economic benefits of the product portfolio
+ Monitor reimbursement trends and policies across assigned geography and accounts
+ Support hospitals and offices with billing and reimbursement inquiries
**Qualifications and Experience:**
+ Bachelor's degree required, Advanced degree(s) preferred
+ 7+ years of experience in market access, payer relations, reimbursement, or a related field.
+ 5+ years of experience working with commercial payers
+ Demonstrated knowledge of U.S. national and regional payer landscape
+ Established relationships with national and regional payer accounts and highly skilled in relationship development
+ Hands-on experience with Medicare Part B reimbursement, hospital outpatient departments and physician office-based reimbursement
+ Experience presenting clinical and health economic data to payer and provider audiences
+ Collaborates with Hologic team members and physician champions to achieve desired outcomes.
+ Excellent organization and communication skills; demonstrated responsiveness to meet the needs of internal and external customers
+ Strong decision-making skills; ability to take initiative and act independently
+ Strong analytical thinking; ability to understand and synthesize complex information
+ Experience working with and managing external vendors
+ Preferred knowledge of drug-device combination products, radiopharmaceuticals, and innovative payment pathways (such as transitional pass-through payment)
**Why join Hologic?**
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $150,300 to $267,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
**Agency and Third-Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
**_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._**
\#LI-KM3
$91k-122k yearly est. 26d ago
Lead Product Security Engineer (R&D Cytology)
Hologic 4.4
Marlborough, MA job
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a Lead Product Security Engineer and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
Key responsibilities and applied experience required from a candidate:
Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices.
Support the creation and maintenance of security design documentation and architecture diagrams.
Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
Define security requirements and controls based on specific use cases and threat models.
Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
Establish automated processes for vulnerability scanning and remediation
Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process
Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
Experiences that are nice to have:
Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA,
GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
Minimum Requirements:
Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
Skilled in working within cross-functional groups.
Skilled in performing Risk Assessment and Management plan
Skilled in writing design documentation and standard operating procedures.
Experience working in an FDA regulated environment is required.
Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Strong verbal & written communication skills.
Familiarity with Windows OS and cloud-based solutions is required
Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
$131.5k-205.8k yearly Auto-Apply 60d+ ago
Senior IT Compliance Analyst
Lemaitre Vascular 4.6
Lemaitre Vascular job in Burlington, MA
The Senior IT Compliance Analyst supports the company's security and compliance initiatives, with a primary focus on the SOX ITGC framework. This role is responsible for developing and implementing internal controls, facilitating audits, and ensuring ongoing compliance with industry standards. The position requires close collaboration with teams across accounting, sales, customer service, legal, and IT to remediate gaps and strengthen business processes. The ideal candidate brings expertise in governance, risk, and compliance, paired with strong analytical and results-driven skills.
Responsibilities
- Work with process owners to assess existing processes and implement improvements that enhance efficiency, standardization, and automation, ensuring that all modifications uphold SOX compliance and robust internal controls
- Lead the design, implementation, and auditing of SOX ITGC, IPE, and ITACs to maintain robust internal controls.
- Serve as the primary liaison with internal and external audit teams.
- Ensure timely collection and organization of compliance documentation.
- Execute technology compliance activities, including risk assessments, privacy impact assessments, and security control testing.
- Identify, remediate, and monitor compliance gaps to drive continuous improvement.
- Develop, refine, and enforce IT compliance policies and standards.
Pay range $90,000-$120,000 per year
The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. Actual base salary pay will be based on a number of factors, including , relevant education, qualifications, certifications, experience, and other job-related factors permitted by law.
Qualifications
Qualifications:
- Education: Bachelor's degree required.
- Experience: Minimum 5 years of professional IT experience, with a focus on ITGC, IPE, and ITACs.
- Technical Skills: Proficiency with SQL, Active Directory, Windows Servers, O365, D365 F&O, and Fastpath.
- Other Requirements: Ability to travel up to 10%, including international travel.
EEO Statement
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at ***************.
$90k-120k yearly Auto-Apply 36d ago
Lead Product Development Engineer - Marlborough, MA
Hologic 4.4
Marlborough, MA job
Lead New Product Development (NPD) Engineer Are you passionate about driving innovation in medical devices? Join our team as a Lead NPD Engineer, where your expertise and leadership will shape the future of surgical technology. About the Role: As the Lead NPD Engineer, you will spearhead the development of cutting-edge surgical devices, ensuring products meet clinical needs and exceed user expectations. You'll collaborate with multidisciplinary teams and bring your vision to life by translating customer insights into successful product strategies and outcomes.
Knowledge & Experience:
* Advanced degree (Bachelor's or Master's) in Systems, Biomedical, Mechanical Engineering, or related field.
* Extensive experience (8+ years with Bachelor's, 6+ years with Master's) in new product development within the medical device industry.
* Deep clinical and technical knowledge in gynecological surgery or related surgical technology.
* Expertise in product architecture, specification development, and clinical application of medical devices.
* Proven track record in leading complex product development programs from concept through to delivery.
Skills:
* Strategic thinker with ability to assess product risks and opportunities, guiding technical and business decisions.
* Proficient in cross-disciplinary engineering, with knowledge of embedded systems and collaborative experience between hardware and software teams.
* Strong ability to translate user feedback into technical requirements and validation methods.
* Exceptional problem-solving and creative ideation skills, with a history of delivering impactful, market-ready solutions.
* Outstanding verbal, written, and presentation communication skills, adaptable to technical and non-technical audiences.
* Skilled in mentoring, knowledge sharing, and fostering continuous improvement within teams.
Behavior:
* Demonstrates sound judgment, initiative, and accountability in project leadership.
* Builds and maintains effective relationships across functions, cultivating a collaborative and engaged culture.
* Proactive communicator who keeps stakeholders informed and integrates diverse perspectives.
* Champions innovation, actively contributing to intellectual property development.
* Represents the voice of the end user throughout the development cycle.
Additional Requirements:
* Ability to travel up to 10% as needed.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and an annual bonus scheme, one of our talent partners can discuss this in more detail with you.
The annualized base salary range for this role is $119,300-186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
LI-#LB2
$119.3k-186.6k yearly 60d+ ago
NPD R&D Engineer 2 - Marlborough, MA
Hologic 4.4
Marlborough, MA job
The Product Development Engineer 2 applies strong technical expertise and customer-centric design principles to support new product development from concept through production. This role requires the ability to work both independently and collaboratively to solve moderately complex engineering challenges, contribute to project documentation, and support manufacturing transfer activities.
Required Knowledge:
In-depth understanding of engineering principles and practices relevant to biomedical or mechanical product development, particularly in the medical device industry.
Knowledge of manufacturing processes such as machining, injection molding, rapid prototyping, and common joining methods.
Familiarity with risk management tools, including the identification, assessment, and mitigation of risks throughout the product lifecycle.
Understanding of design for manufacturability (DFM), geometric dimensioning and tolerancing (GD&T), and tolerance stack-ups.
Proficiency in using CAD software; SolidWorks experience preferred.
Awareness of experimental, computational, and analytical tools such as DFSS, statistical methods (DOE), and MiniTab.
Required Skills:
Ability to independently execute simple to moderately complex design and project tasks with attention to detail and quality.
Strong technical problem-solving skills, with the capacity to formulate and resolve engineering challenges using sound technical judgment.
Excellent technical writing skills, including the ability to prepare engineering reports, protocols, and validation documentation.
Effective verbal and written communication abilities to interact with cross-functional teams, suppliers, customers, and contractors.
Action-oriented with a drive for results and the ability to learn new technical concepts quickly.
Competence in evaluating, selecting, and applying standard engineering techniques and procedures to project tasks.
Required Behaviors:
Customer-focused mindset, ensuring design solutions meet user needs and regulatory requirements.
Collaborative team player, able to work effectively in multidisciplinary project teams.
Proactive approach to learning and expanding technical skills across different areas.
Adaptability, with the ability to receive and incorporate feedback and supervision appropriately.
Detail-oriented and organized, capable of managing multiple tasks and priorities.
Commitment to ethical practices, safety, and compliance standards.
Required Experience:
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with at least 2 years of relevant experience in research and development within the medical device industry, or
Master's degree in a relevant field with 0-2 years of experience in health and/or business communities.
Demonstrated experience supporting product development, from concept through to production and manufacturing transfer.
Exposure to regulatory and quality requirements within the medical device industry is advantageous.
Work Environment and Physical Requirements:
Regularly required to sit, stand, walk, reach, handle objects, talk, and hear.
Must possess close vision, color vision, and the ability to adjust focus.
Ability to lift or move up to 25 pounds and work flexible hours as needed.
Willingness to travel up to 10% as required.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
The annualized base salary range for this role is 76,800-120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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