- Adecco US, Inc. (Cincinnati, OH)
- …. **Must-Have Skills:** + Strong experience with **ISO 14971:2019** ( Risk Management for Medical Devices ), including work performed after 2020. ... medical device industry with expertise in risk management for all classes of medical devices . + In-depth knowledge of statistical techniques to… more
- Medtronic (Mounds View, MN)
- …with these standards: ISO 13485, ISO 14971, IEC 60601. + Experience with risk management for medical devices and ISO 14971. + Demonstrated ability to act ... compassionate world. **A Day in the Life** Principal Systems Risk Management Engineer Careers That Change Lives...(Word, Excel, Access, and PowerPoint) and Windows OS. + Medical device industry experience. + Experience with… more
- Epredia (Kalamazoo, MI)
- …equivalent experience. + 3+ years of practical and theoretical experience with Risk Management to in the Medical Device sector (or similar highly ... will be doing: + Responsible for Risk management activities, including the incorporation of applicable medical...CFR 11, 14971:2019 and ISO 13485:2016 associated with the medical device industry. + Understands and is… more
- Ascensia Diabetes Care (Kalamazoo, MI)
- …equivalent experience. + 3+ years of practical and theoretical experience with Risk Management to in the Medical Device sector (or similar highly ... will be doing: + Responsible for Risk management activities, including the incorporation of applicable medical...CFR 11, 14971:2019 and ISO 13485:2016 associated with the medical device industry. + Understands and is… more
- Hackensack Meridian Health (Brick, NJ)
- …and product problems in collaboration with the Purchasing Dept + Represents the Enterprise Risk Management Department on various medical center committees as ... and serve as a leader of positive change. The ** Risk Management Analyst (RMA)** is responsible for...shall work closely with internal and external counsel, the medical claims TPA, and insurance broker representatives. This position… more
- Sanofi Group (Cambridge, MA)
- …according to ISO 14971 and TIR 57 + Plan, prepare and perform risk management activities for medical devices according to project phases following all ... - 3 years relevant experience in risk management for medical devices +...devices + Strong experience in software development and medical device life cycle management … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …prevention and control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device ... Medical Safety ( Medical Device preferred to Pharma) or Risk Management ( Medical Device ) experience. + Extended periods of time doing… more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Bachelor's Degree and a minimum of 10+ years of Enterprise Risk Management or related experience required, preferably in medical device ; or equivalent ... Director, Enterprise Risk Management Date: Jan 2, 2025...manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range… more
- Philips (Plymouth, MN)
- …manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices . + Actively evaluate projects for ... a critical role in leading Design Assurance/ Risk Management activities on new Image Guided Therapy Device...years' experience working within FDA regulated medical device environments (vascular medical devices /… more
- Amgen (Thousand Oaks, CA)
- …Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC + Strong understanding and experience ... such as Quality System Regulation - 21CFR820, Risk Management - ISO 14971, and EU Medical Device requirements - Council Directive 93/42/EEC. + Strong… more
- Bausch + Lomb (Kirkwood, MO)
- …and Usability Engineering (ANSI/AAMI/IEC 62366). + Application of medical device product standards and design requirements management . + Strong systems ... Tree Analysis. + Command use of Medical Device Documentation Control and Change Management Systems....Design for Six Sigma [DFSS]. - Medical Device Audits - Design Controls & Risk … more
- UCLA Health (Los Angeles, CA)
- …modeling, vulnerability management , and penetration testing. + Ensure that medical devices comply with relevant cybersecurity regulations, standards, and ... Description The medical device security specialist will play...work closely with cross-functional teams to ensure that our medical devices meet the highest standards of… more
- Sutter Health (West Sacramento, CA)
- …Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and Project Management of medical ... medical equipment network integration management experience. * Cybersecurity management experience, preferably with medical devices . * Maintains an… more
- ZOLL Medical Corporation (Broomfield, CO)
- …and maintaining the cybersecurity requirements and design for ZOLL's Medical 's devices . This role will execute key device cybersecurity activities to support ... that make a meaningful difference in people's lives. Our medical devices , software and related services are...related to government compliance and certifications to include DoD's Risk Management Framework (RMF) compliance, Defense Health… more
- Merck (Rahway, NJ)
- …design and manufacture, medical device design controls and device risk management , human factors evaluations, and design verification/validation. ... and lead the portfolio of technical transfer programs for medical devices and combination products for new...collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality… more
- Sanofi Group (Bridgewater, NJ)
- …skills. Proven experience in the development of connected medical devices , preferably within the pharmaceutical and drug/ device combination product ... to lead the design, development, and implementation of connected medical device technologies and ensuring they meet...CFR 820.30 Design Controls, ISO 13485 and ISO 14971 Risk Management . **Soft Skill & Technical Skills:**… more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …component reliability and continuous improvement, establishing and overseeing test methods for device and component reliability. Risk Management and ... record in leadership roles. + 5+ years of functional management experience in a medical device...as the main point of contact for the lifecycle management of released medical devices ,… more
- Dartmouth Health (Lebanon, NH)
- …(6) years of applicable Biomedical/Clinical Engineering, or HTM experience required. * Prior medical device management experience required. * Must have ... Engineering staff by providing operational consultation and support for Risk Management , Medical Equipment hazard... Medical Equipment hazard recalls, incident investigations, and medical device reporting. * Performs other duties… more
- US Tech Solutions (San Bruno, CA)
- …with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management , Design/Process Verification, ... audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release, manage...issues. **Mandatory:** + 5+ years of experience in program management . + Experience in Medical Device… more
- Insight Global (Rahway, NJ)
- …on project timelines Experience supporting injectable product lines Experience with medical device design controls and risk management is a plus. PMP ... BS/MS with 5+ years of industry experience supporting the development of combination devices Understand the medical device and drug development process… more
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