- 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
- 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
- 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
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …62304 and ISO 14971 for medical device software life-cycle processes and medical device risk management , respectively. + Knowledge of medical ... the Digital Unit will assist with executing the security risk management process over the lifecycle of...the Olympus Digital Unit. + Develops threat models for medical device systems whose functionality is supported… 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...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… 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
- ZOLL Medical Corporation (Broomfield, CO)
- …all efforts related to government compliance and certifications to include DoD's Risk Management Framework (RMF) compliance, Defense Health Agency (DHA) Approval ... Functions + Assist in the development of product specific documentation to include Medical Device Equipment + Work directly with government agencies to ensure… more
- Sutter Health (West Sacramento, CA)
- …Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and Project Management of medical ... plans to address gaps and enable successful execution of medical device integration and technology advancement including...and IoT systems * Extensive work experience in project management methods and techniques, including risk and… more
- Sanofi Group (Cambridge, MA)
- …Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as ... 14971 and TIR 57 + Plan, prepare and perform risk management activities for medical ... devices + Strong experience in software development and medical device life cycle management … more
- Eurofins (Boston, MA)
- …Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management . + Foster a culture of ... vision and team to support our clients in the medical device industry across their product innovation,...risk assessments, gap analysis, and adverse test result management . + Life Cycle Management and Outsourced… more
- United Therapeutics (Eden Prairie, MN)
- … Device Development is responsible for leading research and development of medical device products and components used in combination products by applying ... appropriate design control documentation, conduct verification and validation testing, and complete risk management activities. + Develop the design control and … more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …component reliability and continuous improvement, establishing and overseeing test methods for device and component reliability. Risk Management and ... Compliance: + Support QA in Leading Risk Management Activities: Collaborate with the QA team to ensure...record in leadership roles. + 5+ years of functional management experience in a medical device… more
- Meta (Washington, DC)
- …an experienced attorney to serve as Associate General Counsel for Healthcare and Medical Device Compliance on Facebook's Corporate Compliance & Ethics team. This ... business units, with a focus on fraud & abuse, medical device compliance, FDA and analogous international...a broad range of legal and business partners on risk and legal obligations concerning hardware product compliance, FDA… more
- UCLA Health (Los Angeles, CA)
- Description The medical device security specialist will play a crucial role in safeguarding our medical device environment to ensure device integrity ... identify potential security risks and vulnerabilities. Operation and administration of the Medigate medical device security platform. + Ensure Medical … 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 ... plans for assigned projects; this includes ensuring key milestones are tracked, risk management plans are fully developed, deliverables/decisions are agreed upon… 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, ... system issues. **Mandatory:** + 5+ years of experience in program management . + Experience in Medical Device Manufacturing or Software as a Medical… more
- Actalent (Morrisville, NC)
- …AAMI TIR57 Top Skills Details cyber security, risk management , risk assessment,Threat Model,Penetration Testing, medical device Additional Skills & ... Description Our client, a medical device and therapeutics company, is...Skills cyber security, risk management , risk assessment, Threat Model, Penetration Testing, medical … more
- Sanofi Group (Bridgewater, NJ)
- …will be responsible to lead the design, development, and implementation of connected medical device technologies and ensuring they meet the specific needs of ... work experience in the area of connected & digital medical device technologies or equivalent. + Working...CFR 820.30 Design Controls, ISO 13485 and ISO 14971 Risk Management . **Soft Skill & Technical Skills:**… more
- Motion Recruitment Partners (Lake Forest, CA)
- Human Factors Engineer - Medical Device , IEC-60601, HFC Lake Forest, CA **Hybrid** Contract $65/hr - $80/hr Our client is a worldwide medical device ... as HFE Plans, development of Task Analysis to support Risk management activities, planning and conducting usability...of the state-of-the-art methods as applied to life-sciences / medical device industry. + The contracted service… more
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