- Owens & Minor (Alpharetta, GA)
- …industry experience working on development or change management of class I or II medical devices + Knowledge of Quality System Regulations (Design Control and ... scope projects + Ability to interface effectively with health care professionals and medical device customers + Ability to travel both domestically and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …or other technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with ... technical product expertise (Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated medical … more
- Fresenius Medical Center (Lawrence, MA)
- …+ Experience in software development, verification, and standards necessary to meet global medical device regulatory requirements. + Clear understanding of ... a team of software developers to deliver high quality medical device software. Develop and drive a...of experience in hand's-on embedded software engineering roles for medical devices . + Minimum 5 years of… more
- Community Health Systems (Naples, FL)
- …equipment knowledge (manufacturers, models, modalities, capital planning, etc.), + Understanding of regulatory requirements of medical devices (CMS, TJC, ... diagnostic equipment, and laboratory instruments. + Troubleshoots, diagnoses, and repairs malfunctioning medical devices and systems in a timely manner to… more
- Gilead Sciences, Inc. (La Verne, CA)
- … reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination ... provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system (QMS)… more
- Philips (New Kensington, PA)
- …driving the successful execution of complex, cross-functional programs within a regulated medical device environment. This role is responsible for developing ... preferred + 10+ years in program/project leadership within a regulated (preferably medical device ) environment + Proven success managing compliance and … more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the… more
- Knowles Precision Devices (Itasca, IL)
- …Manufacturing Engineer (AME) to lead product and process development initiatives for innovative medical devices (Class I, II, or III). This role is pivotal ... the development and implementation of manufacturing processes for new medical devices or components. + Own Design...field. Masters preferred + 8-10+ years of experience in medical device design, manufacturing, or process engineering.… more
- Philips (New Kensington, PA)
- …Minimum of 8+ years of professional experience in product/solution development within FDA-regulated medical device or technology sectors. + Minimum of 8+ years ... teams, ensuring alignment with strategic business objectives. + Coordinate with Quality, Regulatory , R&D, Operations, and Marketing teams to meet goals related to… more
- Fujifilm (Macedonia, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more