- 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
- Bristol Myers Squibb (Princeton, NJ)
- …the manufacturing sites, device quality group, & product quality group for medical device safety reporting & risk management of the medical ... regulatory authority inspections & internal & external audits as a case management medical device safety SME. Partner with key stakeholders to develop… 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
- Abbott (Pleasanton, CA)
- …product development of medical device industry + Experience focused on risk management activities for regulated medical device , especially with ... influencing requirements, design, and testing as a result of risk management . **What you will do:** +...ASICs, Bluetooth, and NFC technologies + Class III implantable medical device experience, specifically supporting heart failure… 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
- 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
- Merck (Rahway, NJ)
- …activities (eg engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, ... manufacturing process development, qualification and validation, design controls and device risk management techniques to...medical device development, design controls and risk management , alongside deep knowledge in … 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
- Merck (West Point, PA)
- …design and manufacture, medical device design controls and device risk management , human factors evaluations, and design verification/validation. ... product stewardship for several key products in our company's medical device and combination products portfolio. This...will ensure the development and execution of robust lifecycle management plans, proactive risk management … 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
- 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
- Merck (Rahway, NJ)
- …+ Utilize extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop ... advanced degree (Master's or PhD) preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a… more
- Merck (Rahway, NJ)
- …formulation science, preclinical and clinical research. + In-depth knowledge of medical device development, regulatory requirements, and quality standards, with ... development, due diligence assessments, and strategic partnerships in the pharmaceutical or medical device industry. + Ability to inspire, mentor, and develop… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department. This position is a Corporate Quality function ... between departments, CMOs and sites respective to Combination Drug Products and Medical Devices. This position performs the function of Independent Reviewer Role,… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …+ Strong working knowledge of QSR, ISO 13485, MDD/MDR, ISO14971 ( Risk Management ), and Canadian Medical Device requirements. + Experience conducting ... responsible for providing leadership and guidance to the supplier management programs within the Surgery Business Unit (BU) to...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- MetaOption, LLC (Cambridge, MA)
- Medical Device Senior Manufacturing Engineer Skills: Medical Device Manufacturing, Design for Manufacturing (DFM), SolidWorks Proficiency:, Process ... degree or higher in Mechanical engineering. * 5+ years of experience in medical device manufacturing engineering, including at least three years in new… more
- Philips (Plymouth, MN)
- …Core Team Leader responsible for the development and launch of new medical device products supporting Philips Image Guided Therapy Devices business. ... project planning workshops to integrate cross-functional inputs and executing risk management to exploit opportunities and mitigate...acquired 9+ years of product development experience within the medical device industry with at least 2… more
- AbbVie (North Chicago, IL)
- …of principles and practice of Design Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO 14971) + ... with 6+ years of experience (MS preferred) + Experience must include significant device development, with medical device , pharmaceutical or other regulated… more
- Danaher Corporation (Sacramento, CA)
- …includes reviewing and approving design history file documents and owning product safety risk management deliverables. This is not a software testing role. You ... design changes at various project development phases. Ensure that risk management activities are performed per company...a regulated industry, specifically knowledge of IVD and the Medical Device industry The salary range OR… more
- Motion Recruitment Partners (Lake Forest, CA)
- Sr/Principal-Embedded Firmwate Eng.-C/C++, RTOS, Chips, Medical Device Lake Forest, CA **Hybrid** Contract $70/hr - $90/hr Our client located in south Orange ... Chip, and microcontrolers** to add to thier team building medical devices. This is a contract-to-hire, onsite hybrid postion...Experience with CAN and Ethernet 6. Experience in software risk management and writing software requirements 7.… more
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