- Amgen (Thousand Oaks, CA)
- …transform the lives of patients while transforming your career. ** Engineer - Risk Management , Combination Product Operations Risk Engineering ... is currently seeking an Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team....be responsible for contributing to the development and lifecycle management of the Risk Management … more
- Gilead Sciences, Inc. (Foster City, CA)
- … product development projects, with a strong emphasis on design control and risk management activities. . Collaborate with device engineering on new ... Gilead Sciences is looking to hire a **Sr Quality Engineer ** for the Combination Product Development team....for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. . Develop… more
- Gilead Sciences, Inc. (Foster City, CA)
- …combination products comply with applicable standards. + Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other ... trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide. + Work with management ...improvement statistical is preferred. + Knowledge of ISO 14971 Risk Management tools (eg, Hazard Analysis /… more
- Gilead Sciences, Inc. (Foster City, CA)
- … product development projects, with a strong emphasis on design control and risk management activities. + Collaborate with device engineering on new ... combination product development, supporting design verification, validation, and transfer...for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. + Develop… more
- Abbott (Irving, TX)
- …Our location in Irving, TX has an open opportunity for a Principal Design Quality Engineer , Risk Management . This person will be responsible to review and ... It is expected to have a firm understanding of risk management best practices & tools comprehending...Science or closely related discipline is required or relevant combination of education & experience. + Minimum 7+ years'… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …self. Become a **maker of possible** with us. **Position Summary:** This position supports combination product development and risk management of new ... assessments and test methods + Quality engineering representation on combination Product Development Teams + Prepare and present project...Analysis, Statistics, etc.) + Ability to lead creation of risk management files + Ability to develop… more
- AbbVie (North Chicago, IL)
- …Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO 14971) + Strong communication skills (both written and ... Engineer who has experience in development of electromechanical devices/ combination products primarily with a Software Engineering or Electrical Engineering… more
- Amgen (Cambridge, MA)
- …familiar with the following standards and regulations: Quality System Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - ... + Familiarity with standards and regulations such as Quality System Regulation - 21CFR820, Risk Management - ISO 14971, and EU Medical Device requirements -… more
- Dominion Energy (Glen Allen, VA)
- Engineer (Associate to Staff) - Probabilistic Risk Assessment - Innsbrook Nuclear Dominion Energy is committed to providing reliable, affordable, and ... ranks from E5-E9, W1-CW5, or O3-O6, plus appropriate equivalent combination of education and years of experience as outlined...is currently seeking an Associate level to Staff level engineer in PRA. Position will be filled commensurate with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **OBJECTIVE:** The Engineer III will support Takeda's combination product development efforts for use ... test development, in silico development, design verification and validation testing, risk assessments, DHF creation, general project team technical support, and… more