- Fujifilm (Santa Fe, NM)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... responsibilities** + Performs the installation of hardware and software of medical imaging systems, components, and accessories to ensure conformance with… more
- Astrix Technology (Boston, MA)
- …field-based medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of ... Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that… more
- Fujifilm (Helena, MT)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.… more
- Nissha Medical Technologies (Nashville, TN)
- …the purview of EndoTheia, Inc._ EndoTheia, a rapidly growing medical device startup developing flexible endoscopic devices to improve patient outcomes and ... sensors with custom and off-the-shelf imaging subsystems into novel medical devices . + Design, prototype, and optimize...Knowledge of ISO 13485, ISO 14971, and FDA QSR medical device design controls. + Experience with… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …development of complex electronic and software systems required. + Experience with medical device development including regulatory requirements required. ... provide innovative technologies that make a meaningful difference in people's lives. Our medical devices , software and related services are used worldwide to… more
- DEKA Research & Development (Manchester, NH)
- …/ other regulatory requirements. + Identify and make sound decisions regarding medical device reporting to regulatory agencies. + Interface with Third ... Engineer - Team Lead to work in a dynamic Medical Device Research and Development environment. The...focused on one or more of DEKA's innovative, life-changing medical devices . + Responsible for reviewing complaints… more
- Bayer (Indianola, PA)
- …+ Working knowledge on OS such as Windows, Linux flavors; + Coursework in medical device development/ regulatory affairs; + Excellent people skills, ability ... to co-design impactful, front-line solutions; + Empowering professionals: Our medical devices and digital tools are designed...be responsible to design and develop software code for medical device development to deliver a high-quality… more
- Merck (Rahway, NJ)
- …and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, ... the development, commercialization, and transfer and sustained launch of medical devices and combination products globally. +...preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with… more
- J&J Family of Companies (Cincinnati, OH)
- …in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is ... Clinical Performance Reports (SSCP) for Ethicon Endo-Surgery within J&J Global R&D Medical Device sector. **DUTIES & RESPONSIBILITIES** Under supervision and in… more
- AbbVie (North Chicago, IL)
- …with typically 5 or more years of experience. + Familiarity with medical devices , combination products, and/or pharmaceutical industry, inclusive of design ... R&D Device and Combination Product Development (DCPD) function provides device development expertise for Aesthetic Devices and Therapeutic Combination… more