- Cepheid (Miami, FL)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a… more
- Beckman Coulter Diagnostics (Miami, FL)
- …plus if you also possess:Experience working in FDA-regulated industries or medical device manufacturing environments.Professional certifications such as CQE, ... long-term supplier strategies.Independently lead quality workshops and comprehensive supplier development initiatives to strengthen manufacturing process capabilities, product reliability,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …+ Or equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. ... Regeneron is currently looking for a Principal/Staff Device Development Engineer to join our...an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed… more
- US Tech Solutions (San Bruno, CA)
- …with a track record of handling multiple programs and streams of work. + Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + ... production and align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …industry experience, **or** PhD and 0+ years in the field of combination product or medical device development and commercialization is desired. + Minimum of ... in the concept, feasibility, development , qualification and launch phases of device development . Area of focus will include identification of user needs,… more
- Bausch Health (Bothell, WA)
- …drive our collective progress and impact. We are seeking an Executive Director, Clinical Development for our Medical Device Aesthetics business (Solta) to be ... position provides a unique opportunity to drive innovation through the development of new medical device technologies and applications in a fast-paced R&D… more
- Actalent (Plymouth, MN)
- …a highly skilled and experienced Senior Chemist to join our R&D team supporting combination medical device development . This role is ideal for a seasoned ... related technical field. Minimum 5 years of experience in R&D within the medical device or pharmaceutical industry. Proven expertise in combination product… more
- Lilly (Indianapolis, IN)
- …**Minimum Requirements:** + 5+ years of experience in asset/project delivery and/or medical device development & commercialization + Demonstrated Project ... will provide leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination product commercialization… more
- Eurofins (Lancaster, PA)
- … or biotechnology industry is required. + Technical Knowledge: Familiarity with medical device development processes, regulatory requirements, and quality ... the development and coordination of projects through the entire medical device life cycle. This role coordinates activities with various internal and… more
- AbbVie (Pleasanton, CA)
- …(QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + ... Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year… more
- Sanofi Group (Cambridge, MA)
- …relevant field, such as engineering or life sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality ... Our team has released an FDA certified class II medical device titration application. We are gearing...teams + Lead quality engineering support for design and development , and facilitate the application of controls and risk… more
- Danaher Corporation (Cincinnati, OH)
- …related work experience, including 4 years in project/program management (experience in medical device , pharmaceutical, or other regulated industry preferred) . ... Program/Project Management (planning, execution, reporting, etc.) of New Product Development and Product Lifecycle programs including resource utilization, project… more
- Hologic (Newark, DE)
- …+ **Quality Management Systems:** Familiarity with ISO and FDA regulations for medical device design and development . + **Cross-Functional Collaboration:** ... + Familiarity with **ISO and FDA quality systems regulations** , especially for medical device design and development cycles. + Prior experience in **new… more
- Merck (Rahway, NJ)
- …systems. Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and ... with, and a fundamental understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus… more
- Sanofi Group (Morristown, NJ)
- …projects. The incumbent will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development , manufacturing, ... team is a globally diverse team supporting the medical device , combination product, digital health and...part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development .… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …preferred + 10 - 15 years of highly applicable and relevant experience in a medical device development environment + Deep knowledge of embedded systems and ... years of experience in the external and internal cardiac medical device markets. The company was founded...developers, and researchers to provide technical expertise to product development efforts. ESSENTIAL DUTIES + Serve as the lead… more
- Bausch + Lomb (Clearwater, FL)
- …Engineering, Materials Science, or related technical field. 10+ years of experience in medical device development , with deep expertise in intraocular lens ... regulatory functions. The ideal candidate brings a proven track record in ophthalmic device development , particularly in IOL design, inserter systems, and lens… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …ie Oscilloscopes, DMMs, network analyzers, power supplies, etc. + Experience with medical device development is desired Physical DemandsThe physical ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Sanofi Group (Cambridge, MA)
- …stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply ( device development , manufacturing, quality, supply chain) and Global Business ... regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care...technologies, all of which are part of Sanofi's exciting development pipeline. The GRA Device team is… more
- Eurofins (Lancaster, PA)
- …needs, project timeline, and budget + Educate potential clients on Eurofins Medical Device capabilities, offering tailored solutions based on their specific ... companies. The service portfolio supports all stages of the drug development process and all functional areas of bio/pharmaceutical manufacturing, including method… more
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