- Belcan (Thousand Oaks, CA)
- …the following standards and regulations: * Quality System Regulation - 21CFR820 * Risk Management - ISO 14971 * EU Medical Device requirements - Council ... assessments including hazard and probability analysis * Background in medical device development, commercialization and knowledge of manufacturing processes… more
- ManpowerGroup (Rocklin, CA)
- …will be part of the Quality Systems team. The ideal candidate will have risk management /assessment ( medical device ), validation and data ... Needed?** + Bachelor's Degree + At least 2 years of experience in risk management /assessment ( medical device ), validation and data control/integrity +… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- CommonSpirit Health (Englewood, CO)
- …position however candidates located in TN or KY are preferred. The Clinical Engineering Medical Device Security Engineer will be a key member of our Clinical ... Engineering Medical Device Security Team, responsible for maintaining...security or business processes. + Test configurations and deploy risk mitigation strategies in known environments. + Prepare and… more
- Sanofi Group (Cambridge, MA)
- …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
- Lilly (Indianapolis, IN)
- …5+ years of experience with materials engineering in highly regulated industry ( medical device engineering preferred) + Knowledge of polymer materials chemistry, ... to those who need them, improve the understanding and management of disease, and give back to our communities...Lilly devices and for providing technical support to global device manufacturing operations with interface to functional groups inside… more
- Merck (West Point, PA)
- …+ Utilize extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop ... Materials Engineering, or similar **Experience** + 8+ years of experience in medical device or combination product engineering. + Demonstrated technical… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …with plastic design, manufacturing, and assembly + Complete the risk management activities to meet project timescales, device performance and quality ... Description: The Medical Device Engineering Manager is responsible...Marketing, and other departments to create DHF documents including Risk management documents. + Skilled in the… 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
- Sanofi Group (Morristown, NJ)
- …was possible. Ready to get started? **Our Team:** The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... You will be responsible for concept development of innovative medical device technologies, from ideation to proof...from ideation to proof of concept, in order to de- risk late-stage development programs and position us for the… more
- Medtronic (Boston, MA)
- …with 7+ years of managerial experience. **SPECIALIZED SKILLS OR EXPERIENCE:** + Risk management experience in the medical device industry + Risk ... aspects of the company's design and development of new medical device products or software systems. +...+ Significant breadth and depth in quality decision making, risk management , quality engineering, reliability engineering, and… 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
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