- Eclaro (Irvine, CA)
- …network infrastructure components and technologies Implementation of call routing, QoS, device pools, signaling protocols, dial-peers, and partition management ... Teams and Cisco WebEx App Experienced with performing root cause analysis, risk identification, and risk mitigation Support, implement, and troubleshoot voice… more
- Veterans Affairs, Veterans Health Administration (Chillicothe, OH)
- Summary The Risk Manager Quality Nurse (RM/UM) is responsible for the Medical Center Risk Management Program which identifies risk that may adversely ... Boards of Investigation, The Joint Commission sentinel events, Safe Medical Device Act, and National Practitioner Data...reporting experience; along with experience in the following areas: Risk Management , Medical Surgical/ICU Nursing… more
- Adecco US, Inc. (Plainsboro, NJ)
- …62366-1:2015, and other regulatory requirements. If you have experience in risk management within the medical device industry, a strong understanding of ... + **Experience** : 5-7 years of experience in the medical device industry with subject matter expertise...risk management for all classes of medical devices . + **Statistical Expertise** : Strong… more
- Merck (Wilson, NC)
- …experience in MDCP product development or manufacturing operations. + Experience in design controls, device risk management , medical device , ... 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) ... Associate Principal Scientist - Development Strategy, Design Controls and Risk Management ** Our company's Device ...deliverables for medical devices + Recognized as a subject… 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
- Bayer (Whippany, NJ)
- …medical device regulations and industry standards globally for design control, device risk management , and post-market surveillance throughout the ... (Safety Officer) according to |30, Medizinproduktegesetz ( Medical Device Regulation) for medical devices ...least 4 years of professional industry experience in quality management systems relating to medical devices… 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
- 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
- Jabil (St. Petersburg, FL)
- …for Risk Assessment for Jabil Healthcare Corporate site as per Medical devices and application of risk management to medical devices ... position offered or 2 years of experience developing quality management systems for medical device ... manufacturing. Also requires 2 years of experience: applying Risk Management ISO 14971 principles; facilitating workshops… 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
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …component reliability and continuous improvement, establishing and overseeing test methods for device and component reliability. Risk Management and ... record in leadership roles. + 5+ years of functional management experience in a medical device...as the main point of contact for the lifecycle management of released medical devices ,… 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...risk mitigation. + Detect and identify vulnerabilities in devices or systems. + Maintain thorough documentation and complete… 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
- 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
- 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
- Merck (West Point, PA)
- …+ Utilize extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop ... in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a...or similar **Experience** + 8+ years of experience in medical device or combination product engineering. +… more
