- 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...develop and apply value-add solutions to customer needs in medical devices and combination products. + Provide… 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
- Danaher Corporation (Sunnyvale, CA)
- … Assessments, Failure Mode Effect Analysis (FMEA), and Health Severity assessments within the risk management process + Leads medical risk assessments ... with Senior Management . Review and comment on medical risk assessments for complaints; sign-off on...risk assessments for complaints; sign-off on reportability of Medical Device Reports (MDR) + Reviews, updates… more
- Novo Nordisk (Fremont, CA)
- …a difference? The Position The Sr. Engineer will design, develop, test and implement medical devices and device systems to prepare and administer advanced ... technologies, examine possibilities for diverse product solutions. + Oversees risk management activities including development of ...expert for design and development of medical devices representing Medical Device R&D… more
- Compass Group, North America (New York, NY)
- …in response to cybersecurity alerts, ensuring Client KPI's are met, perform audits and risk assessments of medical devices , entail responding to trouble ... complaints and concerns. + Monitors and responds to Clients medical device asset and cybersecurity management...criteria governing the safe and appropriate use, testing and management of medical devices . +… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …assessments, threat modeling, and risk analysis. + Lead efforts to secure devices , including design, patch management and secure coding practices. Project ... that make a meaningful difference in people's lives. Our medical devices , software and related services are...great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines… 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
- 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
- Merck (Columbus, OH)
- …the organization, overseeing the quality assurance and regulatory CMC for complex medical devices , including auto-injectors and other innovative drug delivery ... throughout the product design, development, and manufacturing processes. + Implement risk management principles (ISO 14971) in design and development… 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
- 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
- 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 ... activities related to Design Verification and Design Transfer of Medical Devices + Ensuring work product meets...device development process + You have experience with device risk management activities +… 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) + ... compliance to international standards and regulatory requirements for software and medical devices including cybersecurity; support documentation to ensure… more
- Church & Dwight Co., Inc. (Fort Collins, CO)
- …ISO 13485-2016, and MDSAP requirements. + Experience in application of Risk Management of medical devices (ISO 14791), Electrical Safety Standards, such ... compliance with ISO 13485, MDSAP, ISO 9001, the European Medical Device Regulation, the US Food and...quality evaluation and controls for electromechanical Medical Devices . + Proven leadership, team and change management… more
- WellSpan Health (York, PA)
- …pm General Summary Performs a variety of functions related to implanted cardiac device management in the ambulatory and/or inpatient care settings. These ... + Documents information and reports in Cardiac Implanted Electronic Device (CIED) software and Electronic Medical Record...practices. + Works closely with other members of the device management team to ensure competency and… more
- University of Washington (Seattle, WA)
- …UW quality improvement program. + Develop and deliver clinical risk management education programs for the purpose of medical malpractice prevention as ... ensure compliance with the reporting requirements of the Safe Medical Devices Act.o Identify all events that...(ARM) or certificate program in Healthcare Risk Management (CPHRM). + Experience-based knowledge of medical … 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 ... common goals. The group provides GQ operational support for medical devices and Drug- Device combination...** (Primary Responsibilities) + Establish and maintain the global device risk management processes. +… more
- University of Virginia (Charlottesville, VA)
- …Help coordinate cardiac device FDA recalls and advisories, working with risk management on patient communication along with the Electrophysiology physician ... The Cardiac Device Specialist at UVA Health University Medical...needed. + Educate patients and their families about cardiac device management , including remote monitoring and lifestyle… more
- Lilly (Indianapolis, IN)
- …teams to accelerate time to market of patient centered designs + Coordinate device risk assessments and design control deliverables. This individual is ... delivery systems (eg cartridges, prefilled syringes, combination product delivery devices , and medical devices ). +...human factors) + Experience with design control processes, including risk management and failure modes & effects… more
- Lilly (Indianapolis, IN)
- …teams to accelerate time to market of patient centered designs + Coordinate device risk assessments and design control deliverables: This individual is ... to those who need them, improve the understanding and management of disease, and give back to our communities...delivery systems (eg cartridges, prefilled syringes, combination product delivery devices , and medical devices ). +… more
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