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Boehringer Laboratories jobs - 150 jobs

  • Director of Commercialization - Medical Device - Acute Care

    Boehringer Laboratories Inc. 3.6company rating

    Boehringer Laboratories Inc. job in Phoenixville, PA

    Job Description Director of Commercialization - Medical Device Our exciting growth has identified the need for a Director of Commercialization - Medical Device to join our team! This role is responsible for driving innovation and growth within one of our key business units (Acute Care) by enhancing product performance, leading new product development, and delivering meaningful innovations that improve patient outcomes. The Director ensures that strategic initiatives translate into commercial success through cross-functional leadership spanning innovation, engineering, and product launch. Additionally, the Director plays a critical role in identifying and advancing acquisition opportunities that strengthen our product portfolio and align with long-term company growth. Overview of the Role The Director of Commercialization - Medical Device is a strategic leader responsible for driving innovation, growth, and competitive differentiation within the Acute Care business unit. This role oversees the full product lifecycle-from concept through commercialization-while ensuring alignment with corporate strategy and market needs. Through visionary leadership and cross-functional collaboration, the Director translates clinical insight and market intelligence into commercially successful solutions that strengthen the company's position in the medical device industry. Who You'll Work With You will report to the Vice President of Strategic Development while working closely with staff of professionals geared towards the development and commercialization of medical device businesses for the company. Major Accountabilities: Lead the Acute Care business unit in identifying, evaluating, and executing new product opportunities in alignment with company strategy. Oversee Innovation & Strategy, Engineering, and Strategic Launch teams within the assigned business unit. Guide product ideation and development efforts, using strong clinical insights, thorough market analysis, and technically sound solutions to support them. Direct project execution from concept through development and commercial launch. Duties and Responsibilities Drive Product Lifecycle Excellence: Provide strategic and technical input on sustaining engineering initiatives and product line extensions to improve product performance, ensure regulatory compliance, and maximize profitability across the portfolio. Champion Agile Innovation: Lead design and development efforts for new products guided by a Minimally Viable Product (MVP) philosophy to accelerate innovation, reduce time-to-market, and validate user needs early in the product lifecycle. Cross-Functional Leadership: Collaborate with Quality Assurance/Regulatory Affairs (QA/RA), Marketing, Sales, Manufacturing, and Supply Chain teams to align development priorities, ensure operational readiness, and support seamless adoption of new acute care technologies. Market Validation and Pilot Oversight: Direct Pilot sales efforts to confirm clinical efficacy, user acceptance, and commercial viability; provide data-driven recommendations for go/no-go and scale-up decisions. Product Launch Management: Oversee all aspects of the Product Launch Process, from planning through commercialization, ensuring clear communication, risk mitigation, and alignment with business objectives. Clinical and Industry Engagement: Cultivate strong partnerships with key opinion leaders, surgeons, hospital systems, and other clinical stakeholders to identify unmet needs, influence design priorities, and build advocacy for new solutions. Team Development and Mentorship: Build, mentor, and inspire a high-performing, cross-functional product development team, fostering a culture of innovation, accountability, and continuous improvement. Qualifications Bachelor's Degree in Engineering, Life Sciences, or Business. Advanced degree/MBA preferred. Minimum 5 years of experience in medical device product development, with at least 3 years in a leadership role. Experience leading cross-functional development teams in a regulated environment. Who We Are & What We Do Boehringer Laboratories, Inc. is a US based Medical Device Manufacturer with it's Corporate Headquarters located in Phoenixville, PA. We serve the Acute Care Hospital Market in the US and across the Globe. We have strong product lines in Minimally Invasive Surgery, Acute Care and the Medical Gas spaces. We have a continuous process to grow the company by finding novel devices that improve patient care. We seek to make world-class products that improve patients' lives. We are dedicated to improving our skills to serve our customers, community, and each other. We are a team of professionals passionate in our work. Our Mission: Caring for Lives through Innovation, Quality, and Service. To learn more about our company, visit ********************** . We provide an environment that fosters professional growth while offering an excellent wage and benefits package, including a 401(k) with employer match.
    $164k-246k yearly est. 6d ago
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  • Automation Technician - Medical Device

    Boehringer Laboratories Inc. 3.6company rating

    Boehringer Laboratories Inc. job in Phoenixville, PA

    Job Description Automation Technician - Medical Device As our company continues to grow, we're excited to introduce a new opportunity for an Automation Technician to help drive the next phase of our manufacturing innovation. In this role, you'll be part of a forward-thinking team focused on developing and implementing automation solutions that boost efficiency, quality, and consistency across production. If you're passionate about technology, hands-on problem-solving, and shaping modern manufacturing processes, this is an excellent chance to make a meaningful impact. Overview of the Role The Automation Technician will be instrumental in building and advancing our automation capabilities for manufacturing equipment. You'll design, install, and maintain automated systems that improve performance and reliability while supporting the development of new automation processes from the ground up. This role offers the opportunity to work with cutting-edge technologies in electrical controls, pneumatics, and mechanical systems and to play a key role in helping our organization transition toward a more automated and efficient future. Who You'll Work With You will report to the Manufacturing Manager while working closely with engineers and cross-functional teams. Major Accountabilities: Tests, adjusts, installs, operates, maintains, and inspects computerized systems, robotic devices, control systems, and manufacturing equipment and workstation installations, using skills in electronics, fluid power, mechanics, and manufacturing processes. Monitor and perform routine diagnostic checks, troubleshoots problems, and repairs found issues in automation equipment/control panels to minimize production downtime and maximize efficiency. Perform routine inspections and preventive maintenance on equipment systems and electrical components. Duties and Responsibilities Sets up and conducts tests of complete units and components under operational conditions to investigate design proposals for improving equipment performance or to obtain data for development, standardization, and quality control. Devises, fabricates, and assembles new or modified mechanical components or assemblies for products, such as industrial equipment and machinery, power equipment, machine tools, and measuring equipment. Document all maintenance activities, repairs, system changes, and troubleshooting procedures accurately. Collaborates with Engineering and Manufacturing teams to implement automation solutions that enhance system reliability and performance. Collaborate with Engineering and Manufacturing teams to support equipment upgrades, preventive maintenance, and process improvements. Ensure compliance with safety standards and electrical codes during all phases of work. Qualifications Associate's degree or technical diploma in Electromechanical Engineering Technology, Industrial Automation, or related field. 3-5 years of related experience and/or training; or equivalent combination of education and experience. Strong knowledge of electrical controls (Siemens), ladder logic programming, and control panel wiring. Hands-on experience with pneumatics and mechanical systems integration. Who We Are & What We Do Boehringer Laboratories, LLC is a US based Medica Device Manufacturer with it's Corporate Headquarters located in Phoenixville, PA. We serve the Acute Care Hospital Market in the US and across the Globe. We have strong product lines in Minimally Invasive Surgery and the Medical Gas spaces. We have a continuous process to grow the company by finding novel devices that improve patient care. We seek to make world-class products that improve patients' lives. We are dedicated to improving our skills to serve our customers, community, and each other. We are a team of professionals passionate in our work. Our Mission: Caring for Lives through Innovation, Quality, and Service. To learn more about our company, visit ********************** . We provide an environment that fosters professional growth while offering an excellent wage and benefits package, including a 401(k) with employer match.
    $47k-62k yearly est. 6d ago
  • Associate Neurophysiologist (Hershey, PA)

    Globus Medical, Inc. 4.5company rating

    Hershey, PA 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 Neuromonitoring Specialist/Associate 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 no previous professional experience + Must be CNIM eligible via one pathway as defined by the ABRET website (Bachelor's degree, R EEG T or R EP T certification or a graduate of a CAAHEP or NIM IOM program) + 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 + Obtain and 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.
    $47k-65k yearly est. 30d ago
  • Human Resources Generalist - Programs

    Orasure Technologies 4.5company rating

    Bethlehem, PA job

    OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market. Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions. It's first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. Overview Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease. The HR Generalist - Programs is responsible for supporting and executing key human resources programs that enhance employee engagement, development and retention. This role partners closely with business leaders and HR colleagues to enhance the employee experience and deliver scalable HR initiatives aligned with organizational goals. It collaborates across the HR function to implement initiatives related to talent management, compensation, and learning while providing backup support for talent acquisition and ad-hoc HR projects. The position also requires technical expertise in developing solutions using Power Platform and related technologies.Snapshot of Responsibilities Help to design, implement and manage human resources programs that contribute to an engaged workforce Collaborate with cross-functional teams to ensure HR programs are aligned with business objectives and employee needs. Programs include: the Manager Training Program and Emerging Leaders Program, including ongoing facilitation and improvements; Mentorship program; the Coffee Connection program; the HR SharePoint Site; the Weekly 1:1 App; the Quarterly Touchpoints Apps; the Year End Review App; additional programs as appropriate Monitor program effectiveness through feedback, metrics, and benchmarking Assist with engagement survey analysis and action planning Collaborate with IT to provide specifications to build HR solutions Support annual HR processes, including performance management and compensation planning Provide backup support for Talent Acquisition during peak periods or as needed Lead and participate in our internal employee committees Assist with ad-hoc HRBP support work and special HR projects What You Bring Bachelor's degree in Human Resources, Business Administration, or related field. 2-4 years of HR experience, preferably in program coordination or generalist role. Experience with Power Platform development and related technologies preferred Excellent organizational and communication skills. Ability to manage multiple priorities in a fast-paced environment. Proficiency in Microsoft Office Suite. Familiarity with SharePoint and Teams. OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong. What we have to offer: - Tiered Medical PPO, EPO, Vision and Dental coverage - Disability and Life Insurance Benefits - Generous 401K plan and company-matching contributions - Highly competitive paid time-off - Maternity Leave and Parental Leave Coverage - Employee Referral Program - you may be eligible for a cash bonus if your referrals are hired - Employee Assistance Program - Employee Service Recognition - Job-related Training Programs - Ability to participate in Teams, Committees, Events and Clubs - Depending on the role you may be eligible to work in a hybrid environment or fully remotely - Free Onsite Parking Please note, the above applies to full-time permanent positions. Culture, People & Community OTI recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and the OTI family of companies employees. - LIVE IT Committee - committed to creating an environment that embodies our values - All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book club and mentorship program - Wellness Committee empowers colleagues to make critical decisions to improve and protect health - Sustainability Committee aims to minimize impact on the environment - Social Committee who organize and run events for both remote and onsite employees, to create connection and community At OTI, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by law with regard to any employment practices. OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Katheryn Viau at ****************************. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.
    $65k-90k yearly est. Auto-Apply 44d ago
  • Creo Designer, Graphic Case

    Globus Medical 4.5company rating

    Audubon, PA 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 Creo Designer is responsible for the design, development and documentation including detailed drawings for medical implant and instrument cases (graphic cases) according to specifications provided by Product Development. This effort includes, but is not limited to, bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, etc. This individual works with Product Development and the Graphic Cases department to ensure the cases are being made up to company standards. Essential Functions: Designs/develops and revises medical implant and instrument cases (graphic cases) using Creo Parametric Partners with in-house prototype shop and outside vendors to ensure manufacturability; interact with engineering, manufacturing, and quality personnel to complete required tasks within a project's timeline Reports to Manager, Case Design Creates and maintains project plans and FDA complaint Design history Files (DHF) for each case Ensures timely completion of project tasks, as assigned by manager, while remaining in full compliance with Globus quality system and other applicable regulatory bodies 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: Associates in Mechanical Engineering or similar field 2+ years' experience with Creo Parametric, or similar 3D solid modeling software 1+ years' experience with Windchill PLM software Knowledge of sheet metal manufacturing is a plus Strong hands-on product development experience Excellent verbal and written communication skills Attention to detail Self-starter Advanced critical thinking and problems-solving skills Proficiency in using Microsoft Office products 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.
    $53k-65k yearly est. Auto-Apply 34d ago
  • Accounts Payable Specialist - Level 2

    Globus Medical Inc. 4.5company rating

    Collegeville, PA 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 organized and detail-oriented Accounts Payable Specialist - Level 2 to join our Finance team at Globus Medical. This role is responsible for performing advanced accounts payable functions, ensuring accurate and timely processing of invoices, and maintaining both internal and external relationships. The ideal candidate will have experience in a high-volume, fast-paced environment and a solid understanding of accounting principles and manufacturing operations. Essential Functions: * Process a high volume of purchase order and non-purchase order invoices with accuracy and efficiency. * Review invoices and related documentation for appropriate approvals, coding, and compliance with company policies. * Match invoices to purchase orders and receiving documents in ERP system (e.g., AX, SAP, GlobusOne). * Investigate and resolve discrepancies between invoices, purchase orders, and receiving reports. * Prepare and process weekly payment runs, including checks, ACH, and wire transfers. * Monitor and maintain accounts payable inbox, responding to internal and external inquiries in a timely manner. * Reconcile vendor statements and resolve outstanding issues with vendors and internal departments. * Assist with month-end closing activities, including accruals, aging reports, and account reconciliations. * Support audits by providing documentation and answering inquiries related to AP transactions. * Identify process improvement opportunities and support automation initiatives. * Ensure compliance with internal controls, company policies, and regulatory requirements. * Completes special projects and departmental initiatives 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: * Education: Associate's or Bachelor's degree in Accounting, Finance, or related field preferred. * Experience: 3-5 years of accounts payable experience, preferably in a manufacturing or industrial environment. * Proficiency in Microsoft Office Suite (especially Excel: VLOOKUPs, PivotTables). * Experience with ERP systems such as Concur SAP, AX, Sage, or similar. * Familiarity with 3-way match process and inventory-related invoicing is a plus. * Strong analytical and problem-solving skills. * Excellent attention to detail and organizational skills. * Ability to manage multiple priorities and meet deadlines. * Effective communication and interpersonal 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.
    $61k-74k yearly est. 60d+ ago
  • Model Maker, CNC 5-Axis Milling

    Globus Medical 4.5company rating

    Audubon, PA 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 CNC Model Maker, 5-Axis Milling is responsible for prototype fabrication to support product development. This includes bringing a product from idea/concept through design, prototyping, development, testing, design verification and validation, manufacturing, and product introduction. This individual will also be responsible for maintenance of the machines including calibration, regularly scheduled maintenance, and routine servicing. Essential Functions: Setup, program, and operate CNC 5-Axis Milling Machines to produce prototypes and custom instruments Utilizing various CNC and manual equipment including mills, lathes, and EDM for fabricating models, prototypes, test parts, and low volume production of instruments and implants Participating and providing input in design meetings and ‘brainstorming' sessions Ensuring that all machines and measurement equipment are calibrated regularly as needed and in compliance with Globus' quality system Performing routine maintenance and servicing machines to ensure smooth, trouble free operation Maintaining clean work environment by regular cleaning and upkeep Assisting in process / tooling development for manufacturing Adhering 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 Representing 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: Ability to setup, program and operate 5-Axis Milling Machines including but not limited to GF Mikrons, Hurco, and Haas multi-axis machines 5+ years' experience in Machining/Tool & Die making or model making, preferably in the medical device area a plus Ability to proficiently use CNC and manual mills, lathes, and EDM machines a plus Hypermill and / or Mastercam software experience a plus High school diploma required Proven creative skills in design and ability to improve existing designs Strong self-starter who can work with little or no supervision Ability to manage multiple projects simultaneously and effectively within a fast-paced environment Well organized, detail oriented and team player capable of meeting deadlines Proficient with Microsoft Office 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.
    $57k-69k yearly est. Auto-Apply 60d+ ago
  • Facility Maintenance Janitor, 2nd Shift

    Globus Medical, Inc. 4.5company rating

    Collegeville, PA 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 Facility Maintenance Janitor is a "hands on" position. The individual will be responsible for ensuring that all tasks are performed according to standards and completed daily. In addition, the Janitor will need to prioritize tasks and determine immediate needs. **Hours:** 2:00 pm to 10:30 pm **Essential Functions:** + Completing the following daily tasks in an efficient, timely manner: + Thorough cleaning of the reception and the boardroom areas + Cleaning of restrooms; Re-stocking restroom supplies + Trash removal from all work areas + Cafeteria and coffee station clean up including loading/unloading/ running of dishwasher + Vacuuming all carpeted work areas + Dusting in work areas, including cubicles and blinds + Dust mop and damp mopping of floors, including spot cleaning + Window washing + Ensuring a clean working environment + Assisting manager(s) with ordering and stocking of supplies + Maintaining tidiness (spot trash removal) from parking lots. + Performing seasonal maintenance as needed externally (water plants, snow removal, salting, etc.) + Perform minor maintenance tasks as needed- such as replacing lightbulbs, tending to minor plumbing issues, patching and painting + Meet with vendors and contractors + 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 an Organized, Self -Motivated, Team Player + Minimum of 1-3 years professional cleaning experience in a large facility + Must possess a professional and dependable work attitude + Mechanical aptitude **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 20 pounds and occasionally lift and/or move up to 50 pounds. + Required to possess specific vision 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.
    $48k-57k yearly est. 30d ago
  • Director, Quality

    Globus Medical Inc. 4.5company rating

    Audubon, PA 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 Director of Quality provides strategic leadership and oversight of the company's global quality systems, with direct responsibility for Quality Engineering at the Audubon (HQ) site, International Operations Quality, and Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with company objectives for product safety, effectiveness, and continuous improvement. The Director will collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams to maintain a culture of quality excellence and operational efficiency across all facilities and international markets. Essential Functions: Leadership & Strategy * Develop and execute the global quality strategy aligned with company objectives and regulatory requirements. * Provide leadership, mentoring, and development for the Quality Engineering, International Quality, and Sterile Manufacturing Quality teams. * Serve as a senior quality representative in management review, audits, and regulatory inspections. * Drive a culture of accountability, continuous improvement, and proactive risk management. Quality Engineering * Oversee product quality engineering, including design assurance, process validation, risk management, and post-market feedback. * Ensure robust CAPA, complaint handling, and nonconformance processes. * Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements. * Support new product development and design transfer to manufacturing. International Operations Quality * Oversee quality system compliance at all international manufacturing and distribution sites. * Ensure adherence to global regulatory requirements including MDSAP, EU MDR, Health Canada, PMDA, and TGA. * Harmonize global quality processes and drive consistency across regions. * Support international audits and coordinate responses to regulatory authorities. Sterile Manufacturing Quality * Provide oversight of sterilization validation, monitoring, and requalification programs in accordance with ISO 11135 / ISO 11137 / ISO 17665. * Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs. * Approve sterilization cycles, validations, and deviations. * Support product release and ensure compliance with sterility assurance requirements. Audits, Compliance & Continuous Improvement * Lead or support internal and external quality audits. * Ensure timely closure of audit findings and CAPA actions. * Implement continuous improvement initiatives to enhance quality system performance and product reliability. * Monitor and report key quality metrics to executive management. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications: * Minimum BS degree or equivalent in Science or Engineering. A relevant post-graduate qualification would be an advantage but not essential * Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections * Experience in product quality assurance, process quality, verification and validation * Experience with electro-mechanical medical devices, including software, is desired * ASQ Certification or equivalent formal training and experience is desired. Multi-discipline assurance background is desired. Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus * Demonstrated knowledge and understanding of the Quality System Regulations (FDA) and standards, ISO 13485, and other related regulations with emphasis in problem solving and CAPA Systems * Computer proficiency with MS Office and statistical analysis tools is required; Must be able to make solid decisions that effectively support the business and company policies * Presentation skills and ability to train personnel in quality matters * Travel requirements are as needed 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.
    $91k-107k yearly est. 32d ago
  • Manager, Internal Audit

    Globus Medical 4.5company rating

    Collegeville, PA 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 Manager, Internal Audit is responsible for evidencing Sarbanes-Oxley compliance, including; design, scope, documentation, design effectiveness, testing and remediation while providing support and guidance to management in their assessment of the effectiveness of internal controls. Additionally, The Manager, Internal Audit will also be instrumental in assisting with preparing the company for continued SOX compliance. Essential Functions: Assists with development, execution and enhancement of SOX control environment, including but not limited to the listed business processes: revenue, inventory, fixed assets, payroll, treasury, accounts payables, accounts receivables, taxes, goodwill and intangibles, ITGCs etc. Assists in risk assessment, entity level controls testing, segregation of duties and SOC1 reports review Prepares testing documentation evidencing adequacy and effectiveness of management's controls, business risks, related exposures, and providing value added recommendations and corrective actions Obtains and reviews evidence ensuring audit conclusions are well-documented. Ensures adherence at all times to all applicable department and professional standards Communicates issues to the VP to ensure any potential concerns are addressed in a timely and effective manner Assists with the continued refinement and execution of SOX assessment test plan Assists in establishing, testing and documenting the controls of the newly acquired entities Assists the VP in preparing audit reports for Senior Management and Audit Committee Manages and have oversight responsibilities of staff and seniors, as appropriate. 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 in accounting, finance, or a related business discipline CPA required; MBA/CIA a plus (but familiarity with IT systems and SOX testing is required) Minimum 5 years solid accounting experience required with 2 years public accounting and / or internal control testing experience Familiarity with US GAAP and PCAOB Auditing Standards; strong knowledge of SOX 404 compliance, COSO 2013 and internal control assessment Experience in identifying risks associated with processes (risk assessment), identifying internal controls within a process and performing gap analysis Manufacturing and international industry experience preferred Requires proficient knowledge of business systems and Microsoft Office applications Requires demonstrated ability to be objective and use exceptionally good judgment Self-starter with the ability to work independently; has a high level of ethical awareness and conduct Well organized, detail-oriented team player with proven ability to multitask effectively Excellent communication skills and ability to effectively lead a discussion or meeting Ability to travel up to 15% 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.
    $60k-74k yearly est. Auto-Apply 59d ago
  • Quality Control Inspector

    Globus Medical, Inc. 4.5company rating

    Limerick, PA job

    Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus' world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. **Position Summary:** The Quality Control Inspector is responsible for performing QC inspections and package testing on in-process materials and finished products. The QC inspector will also be responsible for ensuring all policies and procedures in compliance with applicable FDA, state, OSHA, AATB, and ISO regulations and standards. **Essential Functions:** - Performs quality control inspections on manufacturing supplies, labels, in-process materials, and sterile packed finished products. - Performs peel testing of sterile product seals. - Follows verbal and/or written instructions such as production traveler/batch record, work instruction, and process specifications at the direction of supervisor in completing a variety of inspection tasks. - Document non-conformances when found. - Bringing problems/issues to attention of Quality Control Supervisor. - Always Practice Good Manufacturing Practices and Inspection techniques. - Work efficiently to achieve targeted goals as set by the production schedule. - Follow proper safety precautions. - Maintains the quality control lab and work areas in an organized manner. - Verifying inspection equipment, machinery and tools used are calibrated per company policy. - Team player, open to new ideas and teamwork, self-motivated individual, willingness to continually strive to increase personal knowledge and value. - Performing other duties as assigned, to maintain efficiency throughout the company. - 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 required - Minimum one (1) years' experience with quality control inspections is preferred. - Ability to use standard measuring equipment (i.e. Micrometers, Calipers, Height Gages, profilometer, ring, plug and thread, go no/go gages, dial indicator, surface plate, gage blocks and torque wrench) - Excellent verbal and written communication skills - Reliable, self-starter with the ability to work with little or no supervision and is detail oriented. - Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus. - Familiarity with GMP and SOPs to ISO standards a plus. - Strong clerical and math skills. - Must be a flexible team player capable of working in a deadline dictated environment. - Strong organizational, problem solving, and follow-up skills; Ability to work in a fast-paced environment while multi-tasking and maintaining attention to detail. - Proficiency in using Microsoft Office products. **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 vision 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 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.
    $42k-51k yearly est. 23d ago
  • Associate Spine Specialist (Indianapolis + Bloomington, IN)

    Globus Medical Inc. 4.5company rating

    Indiana, PA 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 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.
    $70k-82k yearly est. 20d ago
  • Neurophysiologist Regional Traveler (Mid-Atlantic)

    Globus Medical 4.5company rating

    Pennsylvania 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 and 100% travel within the Mid-Atlantic region. 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.
    $66k-78k yearly est. Auto-Apply 58d ago
  • Exhibits Manager

    Globus Medical 4.5company rating

    Audubon, PA 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 Exhibits Manager will be responsible for the planning, coordination and budget of domestic and international trade shows and society meetings from strategic planning through logistics. This role requires interaction with various levels of management in marketing, product development, and sales, as well as Key Opinion Leaders in the industry. Strong attention to detail, great communication skills, and exceptional organizational skills are a must. This team member does not have direct reports, but will contribute to the overall team success by identifying problems and proactively seeking improvement. Essential Functions: Manage booth layout creation and delivery with the show management and graphics department Plan and implement Globus Medical participation in Society conferences and trade shows (hotel, flights, booth services, shipping etc) Work with management and tradeshow vendors to ensure implementation is within budget and on-time Manage on-site activities including, booth set-up, dismantle, reception, workshops, labs and other promotional activities Collaborate with members of the Marketing team to develop all tradeshow marketing assets Collaborate with Product Development and Product Marketing Operations to secure product and equipment for demonstration purposes Collaborate with Surgeon KOL's to ensure the content of workshops is effective and within regulatory and compliance guidelines Maintain all Exhibits trackers, reports and calendars Create pre and post-show reports on performance and attendance for each show Coordinate and keep track of tradeshow inventory and shipping schedules to ensure timely arrival of materials at tradeshows. 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 4-6 years of current, relevant meeting and event management experience and/or trade show coordination; tradeshow experience strongly preferred High degree of computer literacy and proficiency in Microsoft office suite Excellent verbal and written communication skills Ability to quickly learn scientific and technical knowledge Creative thinker with acute attention to detail within demanding deadlines Ability to multi-task and prioritize timelines under tight schedules Exceptional sourcing and negotiation skills Ability to recognize problems and to think on your feet to find the best solutions Self-motivated positive individual that will work as a team player Proactive with fresh ideas and creative solutions Excellent interpersonal skills, decision making and customer service skills required International event and meeting planning experience is a plus Experience managing events for the medical device or pharmaceutical industries is a plus Ability to travel 20% including weekends 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.
    $74k-89k yearly est. Auto-Apply 6d ago
  • Design & Fabrication Engineer

    Boehringer Laboratories Inc. 3.6company rating

    Boehringer Laboratories Inc. job in Phoenixville, PA

    Job Description Medical Device - Design and Fabrication Engineer Our exciting growth has identified the need to add a Design and Fabrication Engineer to join our team! The ideal candidate thrives at the intersection of design and fabrication, ensuring prototypes meet performance, quality, and manufacturability requirements while collaborating closely with engineers and cross-functional teams. Overview of the Role This role will play a key role in developing innovative medical devices by transforming early design concepts into functional prototypes and production-ready components. This hands-on position combines machining, CAD/CAM design, and 3D printing expertise with problem-solving skills to accelerate product development in a fast-paced startup environment. Who You'll Work With You will report to the Engineering Manager while working closely with project engineers and cross-functional teams. Major Accountabilities: Contributes to product designs based on defined customer needs, including adapting existing designs for new applications, from early sketches to detailed engineering drawings. Construct and test prototypes, components, and assemblies under real-world operating conditions to evaluate design concepts, improve performance, and generate data for development and quality control. Diagnose technical issues and recommend solutions, including design modifications, material substitutions, or component reconfigurations. Duties and Responsibilities Analyze and interpret test results against design specifications and make necessary design or equipment adjustments. Lead the fabrication of prototypes that meet both customer and internal requirements. Support the transition of new products into manufacturing, ensuring cost-effectiveness, manufacturability, and high-quality standards. Prioritize tasks and allocate resources effectively to meet project deadlines. Coordinate with cross-functional teams to ensure design, prototyping, and manufacturing alignment. Organizes and schedules events and resources to ensure all deadlines are met. Qualifications Associate's degree in Engineering, Machine Tool Technology or equivalent combination of education and experience in a design and fabrication role. Minimum of 5 years related work experience Proficiency in manual machining (lathe, mill, grinder) and familiarity with CNC programming and operation. Strong CAD/CAM skills (SolidWorks) for design and prototyping. Hands-on experience with additive manufacturing / 3D printing technologies (FDM, SLA, SLS), including machine operation, material selection, and post-processing. Understanding GD&T, material properties (metals, plastics, composites), and standard manufacturing practices. Excellent problem-solving ability with a hands-on, iterative approach to design and build cycles. Self-starter comfortable in a fast-paced startup environment with shifting priorities. Strong organizational skills with the ability to manage multiple projects simultaneously. Effective communicator with engineers, technicians, and cross-disciplinary stakeholders. Who We Are & What We Do Boehringer Laboratories, LLC is a US based Medica Device Manufacturer with it's Corporate Headquarters located in Phoenixville, PA. We serve the Acute Care Hospital Market in the US and across the Globe. We have strong product lines in Minimally Invasive Surgery and the Medical Gas spaces. We have a continuous process to grow the company by finding novel devices that improve patient care. We seek to make world-class products that improve patients' lives. We are dedicated to improving our skills to serve our customers, community, and each other. We are a team of professionals passionate in our work. Our Mission: Caring for Lives through Innovation, Quality, and Service. To learn more about our company, visit ********************** . We provide an environment that fosters professional growth while offering an excellent wage and benefits package, including a 401(k) with employer match.
    $57k-73k yearly est. 4d ago
  • Senior Regulatory Specialist

    Globus Medical, Inc. 4.5company rating

    Audubon, PA 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 Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations. **Essential Functions** **:** + Partners with Product Development and management to prepare and review 510(k) submissions + Prepares final 510(k) submissions and obtaining required management approvals + Submits 510(k) documents and responding to the FDA in a timely manner + Assists in the completion of IDE and PMA submissions for IDE clinical trials + Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections + Works with personnel in various functional areas to obtain timely submissions to FDA + Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports + Trains new staff on relevant Regulatory processes as necessary + Determines Regulatory Pathway for new/changed products under departmental guidelines + Reviews and approve Regulatory Pathway Forms and supporting documentation + Reviews and approves Note-to-File documentation for minor changes to 510(k) cleared products or systems + Understands the company's products, surgical techniques and the use of implant and instrument systems + Develops relevant Regulatory SOPs as necessary + 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 minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + Solid understanding of regulatory terminology, pre-market submission types, and requirements + Able to evaluate regulatory impact of proposed product and process changes + Capable multi-tasking skills with the ability to project plan and meet deadlines + Result driven with a sense of responsibility, urgency and ability to perform under pressure **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.
    $63k-76k yearly est. 58d ago
  • Facility Maintenance Janitor, 2nd Shift

    Globus Medical Inc. 4.5company rating

    Collegeville, PA 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 Facility Maintenance Janitor is a "hands on" position. The individual will be responsible for ensuring that all tasks are performed according to standards and completed daily. In addition, the Janitor will need to prioritize tasks and determine immediate needs. Hours: 2:00 pm to 10:30 pm Essential Functions: * Completing the following daily tasks in an efficient, timely manner: * Thorough cleaning of the reception and the boardroom areas * Cleaning of restrooms; Re-stocking restroom supplies * Trash removal from all work areas * Cafeteria and coffee station clean up including loading/unloading/ running of dishwasher * Vacuuming all carpeted work areas * Dusting in work areas, including cubicles and blinds * Dust mop and damp mopping of floors, including spot cleaning * Window washing * Ensuring a clean working environment * Assisting manager(s) with ordering and stocking of supplies * Maintaining tidiness (spot trash removal) from parking lots. * Performing seasonal maintenance as needed externally (water plants, snow removal, salting, etc.) * Perform minor maintenance tasks as needed- such as replacing lightbulbs, tending to minor plumbing issues, patching and painting * Meet with vendors and contractors * 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 an Organized, Self -Motivated, Team Player * Minimum of 1-3 years professional cleaning experience in a large facility * Must possess a professional and dependable work attitude * Mechanical aptitude 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 20 pounds and occasionally lift and/or move up to 50 pounds. * Required to possess specific vision 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.
    $61k-73k yearly est. 31d ago
  • Associate Internal Auditor

    Globus Medical Inc. 4.5company rating

    Collegeville, PA 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 recruiting for an Associate Internal Auditor to work within our dynamic Internal Audit function. This person will work closely with the Internal Audit Director and Internal Audit team in the execution of the board approved internal audit plan. Responsibilities include assisting in the development and execution of the annual risk assessment and taking an active role in testing the design and operating effectiveness of internal controls over financial reporting. It is also anticipated that there will be other non-SOX / Internal Audit projects as time and experience allow. The ideal candidate is a self-starter, detail-orientated, organized and deadline driven. The candidate will also possess strong communication skills, a "roll your sleeves up" mentality and be able to work in a fast-paced environment with changing priorities. Essential Functions: * Assists in completion of the annual risk assessment, entity level controls testing, segregation of duties and SOC1 reports review. * Prepares testing documentation evidencing adequacy and effectiveness of management's controls, business risks, related exposures, and providing value added recommendations and corrective actions. * Obtains and reviews evidence ensuring audit conclusions are well-documented. * Communicates identified issues to the Manager to ensure any potential concerns are addressed in a timely and effective manner. * Assists with the continued refinement and execution of the SOX assessment test plan. * Assists in establishing, testing and documenting internal controls of newly acquired entities. * Adheres to the letter and spirit of the company Code of Conduct and professional standards. * 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 upholding 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. Qualifications: * Bachelors in accounting, finance, or other business discipline * CPA; MBA/CIA a plus * 0-3 years accounting experience required * Familiarity with US GAAP and PCAOB Auditing Standards. Good knowledge of SOX 404 compliance, COSO 2013 and internal control assessment * Experience in identifying risks associated with processes (risk assessment), identifying internal controls within a process and performing gap analysis * Manufacturing and international industry experience preferred * Knowledge of business systems and Microsoft Office applications * Demonstrated ability to be objective and use exceptionally good judgment * Self-starter with the ability to work independently * Well organized, detail-oriented team player with proven ability to multitask effectively * Excellent communication skills and the ability to effectively lead a discussion or meeting 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.
    $63k-75k yearly est. 60d+ ago
  • Manager, Regulatory Affairs

    Globus Medical 4.5company rating

    Audubon, PA 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 Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products. This position entails management of submissions to the FDA, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with the FDA, surgeon investigators, researchers, and Globus personnel. This individual must adhere to FDA 21 CFR regulations in all duties. Experience should demonstrate dependability, flexibility and maturity. Individual must be able to travel up to 10% of the time. Essential Functions: Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing. Develops Regulatory team expertise in project management, writing, testing methods, and product knowledge, and maintains staffing needs to support all current and near term US filings. Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement. Works with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed. Reviews and approves Document Change Orders for US Regulatory, including Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines. Reviews and files Note-to-File documentation with engineering rationales for qualifying changes to 510(k) cleared products or systems and line extensions. Assists in review of product labeling and marketing materials. Provides regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products. Assists in development of relevant regulatory SOPs and training staff as necessary. Ensures conformance to 21 CFR regulations. Assists with other regulatory matters as requested. Attends FDA meetings as requested. Understands relevant surgical techniques and clinical use of implant/instrument systems. 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: BS degree in engineering or science-related field, or equivalent. Master's degree preferred. Minimum of 8 years' experience in the medical device industry, or equivalent. Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably with orthopedic or spinal devices. Demonstrated experience in obtaining 510(k) clearance. Demonstrated experience with IDE and PMA approval, preferably including panel-track PMA. Excellent verbal, written and organizational skills. Must be detail oriented. 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.
    $74k-93k yearly est. Auto-Apply 60d+ ago
  • Electromechanical Technician

    Globus Medical 4.5company rating

    Eagleville, PA job

    Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus' world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. Position Summary: The Electromechanical Technician is responsible for constructing and repairing electro-mechanical medical devices in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment. This individual works with the entire department, to ensure all products made align with blueprints. Essential Functions: Installs electrical and electronic parts and hardware in housings or assemblies, using soldering equipment and hand tools. Aligns, fits, and assembles component parts, using hand tools, power tools, fixtures, and templates. Reads blueprints, schematics, diagrams, manufacturing instructions and work orders to determine methods and sequences of work to be performed. Repairs, rework, and calibrates assemblies and systems to meet operational specifications and tolerances. Verifies dimensions and clearances of parts to ensure conformance to specifications, using precision measuring instruments. Performs routine maintenance on equipment and determines best course of maintenance protocol, including troubleshooting issues when necessary Tests products and/or subassemblies for functionality or quality. This may include performing test protocols for product qualifications, and troubleshooting problems with equipment, devices, or products. Generates assembly records for system Device History Records (DHR) Maintains a neat and organized work area (5S methodology) Separates scrap or waste materials for recycling, reuse, or environmentally sound disposal. 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: High School Diploma or its equivalent with at least one year of experience in the field or in a related area Ability to use a variety of tools and equipment (torque wrenches, hand tools, power supplies, meters, fixtures, soldering irons and tooling) Familiarity with GMP environment; reading & checking Bills of Materials, schematics, and machine/assembly drawings Ability to work under minimum supervision with a high degree of organizational and technical competence. Ability to function well under pressure and expend effort to meet schedules and deadlines. Experience working for a medical device manufacturer or equivalent preferred. Excellent verbal and written communication skills. Attention to detail. Self-starter. Advanced critical thinking and problems-solving 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; stoop, kneel, crouch or crawl and have limber use of hands. Required to regularly lift and/or move up to 20 pounds and occasionally lift and/or move up to 50 pounds. Required to possess specific vision 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 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.
    $50k-57k yearly est. Auto-Apply 60d+ ago

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