- Merck & Co. (Rahway, NJ)
- …injection. This position will be responsible for leading and implementing medical device and combination product design controls and risk management ... Principal Responsibilities-Lead/contribute to device development, design controls and risk management strategy for the assigned projects.Lead the… more
- Merck & Co. (Rahway, NJ)
- …commercialization.Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control ... in method development, validation, and testing within the pharmaceutical, medical device , or combination product (preferred) industry.Demonstrated leadership… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main ... include the following: Partner with the Design Control and Risk Management leads to determine the data...Technology, Engineering, or Math (STEM) field0-2 years in the medical device or pharmaceutical industry. Required experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Portfolio Management : Provide portfolio level strategic guidance of the device portfolio, including medical devices, diagnostics, and digital health ... and market dynamics. It will also include commercial ownership of portfolio level device strategy and lifecycle management of devices. Relationships Reports to… more
- Aequor (Thousand Oaks, CA)
- …development and commercialization or R&D in a life science, pharmaceutical, biotechnology, medical device cGMP environment. GMP environment work experience and ... for leading cross-functional teams in new raw material onboardings, life-cycle management projects, and continuous improvement initiatives. This will require working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Merck & Co. (Rahway, NJ)
- …Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant includes clinical or basic research in a pharmaceutical company, a medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck (Wilson, NC)
- …focus on MDCP product development or manufacturing operations. + Experience in design controls, device risk management , medical device , combination ... ISO 13485 standards and relevant MDCP regulations. + Utilize device risk management tools to...with injection molding and working with medical device suppliers. + Experience leading Quality Management … more
- Sanofi Group (Cambridge, MA)
- … planning, hazard and harms list, Risk management reports ) and assists medical device sites in ensuring that risk management is performed in ... Ready to get started? **Our Team:** The Global Quality Medical Device (GQMD) group's mission is to...** (Primary Responsibilities) + Establish and maintain the global device risk management processes. +… 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
- Merck (Rahway, NJ)
- …Has broad knowledge of medical device development, design controls and risk management + Led and managed development of DHF (design history file) ... be responsible for leading and implementing medical device and combination product design controls and risk... device and combination product design controls and risk management activities for both new products… more
- Globus Medical, Inc. (Audubon, PA)
- …statistical quality control, and risk management . + Experience in the medical device industry preferred. + Candidates must be able to work independently ... At Globus Medical , we move with a sense of urgency...and regulatory compliance, including methods and applications for product risk management , process management , process… more
- Edwards Lifesciences (Irvine, CA)
- …and Process Validation + Knowledge of and experience with risk management /usability engineering within medical device industry or other regulated ... new product development projects by applying design control and risk management principles to positively influence new...knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820,… more
- Novo Nordisk (Fremont, CA)
- …therapeutics. By providing subject matter expertise to product development teams for medical device and biologic/ device combination products, the engineer ... Lead and work within cross-functional teams to develop new medical device designs to solve a wide...technologies, examine possibilities for diverse product solutions. + Oversees risk management activities including development of … more
- ZOLL Medical Corporation (Chelmsford, MA)
- …our team. It's a great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines technical expertise with project ... management skills to drive cybersecurity initiatives across a portfolio of medical device products. This role involves hands-on work as well as overseeing the… more
- Terumo Medical Corporation (Somerset, NJ)
- …member of the TMC Quality Management Leadership Team. 2. Oversee medical device complaint processing in compliance with applicable regulations and standards ... and compliance issues, including regulatory and procedural interpretations, processes such as risk assessment, investigation, medical device reporting and… more
- Compass Group, North America (New York, NY)
- …rectify valid operator complaints and concerns. + Monitors and responds to Clients medical device asset and cybersecurity management platform findings and ... Ambulatory EVS. Learn more at www.Crothall.com. Job Summary The Medical Device Integration and Cybersecurity specialist will...alerts, ensuring Client KPI's are met, perform audits and risk assessments of medical devices, entail responding… 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
- 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
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