- Merck (West Point, PA)
- …of medical devices and combination products globally. Experience in design controls, device risk management , medical device , combination ... to our Company strategy and business goals + Utilize device risk management tools to...design control, risk analysis and change control management for medical device or… more
- Amgen (Cambridge, MA)
- … - ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong background in documenting requirements and ... transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** Let's… more
- AbbVie (North Chicago, IL)
- …for this position + 0-5 years of experience in drug risk management and/or medical device / combination product vigilance (safety signal detection, ... device development process in a global medical device company and preparation risk management plans, aggregate reports and company core safety… more
- Globus Medical, Inc. (Methuen, MA)
- …Python, programming experience preferred. + Familiarity with design control processes, risk management , and medical device regulations (FDA 21 CFR Part ... the verification of complex electro-mechanical hardware systems to ensure compliance with medical device standards and design requirements. You'll work closely… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- … experience: + IEC 62304 and IEC 14971 for software lifecycle and risk management + Medical device regulations and standards (eg, FDA, ISO 13485). + ... bioMerieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving… more
- Walgreens (Deerfield, IL)
- …and in managing software development projects + Experience with program risk management + Experience with medical device software development and ... resources to address critical issues and needs. + Establishes a risk management plan for each project. Anticipates, captures, and manages program risks,… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …of embedded systems engineering disciplines, requirements management , safety risk management , and Class 3 medical device considerations + Commitment ... years of experience in the external and internal cardiac medical device markets. The company was founded...to highly cross-functional product definition efforts + Provide safety risk management resources to all projects +… 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: Apr 28, 2025...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Teleflex (Morrisville, NC)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management , and medical device Quality Management Systems ... BS Degree in Engineering (or related technical field) + 0-2 years related ( medical device preferred) experience **Specialized Skills / Other Requirements** +… more
- AbbVie (North Chicago, IL)
- …combination products. + Design, develop and deliver a comprehensive risk management program for pharmaceutical, combination and medical device products ... Minimum of 6 years experience with Quality Assurance and/or Quality System oversight. Risk Management and Device regulations experience is required. LINK-US… more
- Amgen (Cambridge, MA)
- …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
- Amgen (Cambridge, MA)
- … (ISO 13485); + Risk Management (ISO 14971); + EU Medical Device requirements (Council Directive 93/42/EEC); + Medical Electrical Equipment (EN ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- Rush University Medical Center (Chicago, IL)
- …equipment uptime, standardization, and interoperability across RUSH facilities. Lead risk management efforts related to medical device security, recalls, ... system. Knowledge of cybersecurity best practices for biomedical equipment and medical device integration. **Physical Demands:** Ability to work within… more
- AbbVie (North Chicago, IL)
- … Device Quality SME on software classification review board + Support risk management / FMEA activities for device software & mobile apps. + Drive change ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the global… more
- Takeda Pharmaceuticals (Boston, MA)
- …innovative research projects and mentoring teams. + Understanding of the elements of risk management , device risk analysis; identification, estimation ... you to shine? Join us as an Associate Director, Medical Device Safety Specialist in our Cambridge,...reporting requirements for devices, support for post-market surveillance and risk management processes aimed at maintaining the… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a Director, Sourcing Medical Device Management ? At HealthTrust, you come first. HCA Healthcare has ... you have the opportunity to make a difference. We are looking for a dedicated Director Sourcing Medical Device Management like you to be a part of our team.… more
- Organon & Co. (Jersey City, NJ)
- …+ Contribute towards the development of Design History Files. + Support development of Device Risk Management as needed. + Participate on Organon teams ... devices. + Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016), Risk ... device regulations (21CFR820, MDD, ISO 13485:2016), Risk Management Experience (ISO 14971:2012). + Demonstrate… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …technical reports as well as documents for Design History Files + Participating in device risk management activities including UFMEA, DFMEA, PFMEA + Aiding ... We are currently looking to fill a Medical Device Quality Engineer position. This...device development process + You have experience with device risk management activities +… more
- Integra LifeSciences (Plainsboro, NJ)
- …patient outcomes and set new standards of care. The **Sr.** **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the ... corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device … more
- Compass Group, North America (Mooresville, NC)
- …with Computerized Maintenance Management Systems (CMMS) * Knowledge of connected medical device asset discovery and risk analysist platforms EDUCATION: ... ESSENTIAL DUTIES AND RESPONSIBILITIES: * Monitors and responds to Crothall's comprehensive medical device asset and cybersecurity management platform… more
Related Job Searches:
Device,
Management,
Medical,
Medical Device,
Medical Device Management,
Medical Management,
Medical Risk Management,
Risk,
Risk Management