- US Tech Solutions (New Albany, OH)
- …junior engineers. **Skills:** + BS in Engineering and previous experience in a medical device industry + 10 years current experience with engineering processes ... (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. + Experience in drug / device combination product design and development +...21CFR820 o Risk Management ? ISO 14971 o EU Medical Device requirements ? Council Directive 93/42/EEC… more
- Veterans Affairs, Veterans Health Administration (Phoenix, AZ)
- …and recalls. The incumbent can manage a recall and safety alert program for medical equipment, including medical device hazard investigations, to assure ... basis with limited oversight by senior biomedical engineers. They participate in medical device hazard investigations, to assure compliance with patient safety… more
- Stryker (Portage, MI)
- …Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) ... maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards. + Demonstrated strong understanding… more
- Veterans Affairs, Veterans Health Administration (Madison, WI)
- …professional Biomedical Engineering expertise. Serves as the technical expert on VA's Medical Device Protection Program (MDPP). Serves as a technical advisor ... Summary The Biomedical Engineer supports and advances patient care by applying...to the VA information technology network. Responsible for managing medical device network connections and ensuring connectivity… more
- Alaska Airlines (Seatac, WA)
- …to hear from you. **Role Summary** Alaska Airlines is seeking a Flight Simulator Engineer to join the team to provide support and expertise in Flight Simulator ... effort to bring closure to complex technical issues. + Associate Simulator Engineer (P1): The Simulator Technician III maintains the flight simulator and support… more
- Stryker (San Jose, CA)
- …** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) ... strong technical skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in… more
- DEKA Research & Development (Manchester, NH)
- …a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device Research and Development environment. The position reports to the Product ... / other regulatory requirements. + Identify and make sound decisions regarding medical device reporting to regulatory agencies. + Interface with Third… more
- Integra LifeSciences (Plainsboro, NJ)
- …policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations ... set new standards of care. The **Sr. Q** **uality Engineer / Quality Operations (Validations, Risk Management & Statistics)**...Drug Administration (FDA) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian … more
- Lilly (Indianapolis, IN)
- …A minimum of 2 years of work experience in GMP regulated pharmaceutical and/or medical device industries is required. + Background in sterile barrier and/or deep ... Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and… more
- ManpowerGroup (Savannah, GA)
- Our client, a leading organization in the medical device manufacturing industry, is seeking a dedicated and experienced Quality Engineer to join their team. ... 7-10 years of experience in quality engineering within the medical device industry. + Significant experience with...completion of waiting period consultants are eligible for:** + Medical and Prescription Drug Plans + Dental… more