- Stryker (Irvine, CA)
- …venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat ... knowledge to support Voice of Customer sessions + Ensure compliance with industry standards and mentor others in design...design for manufacturing practices + Prior experience in the medical device or healthcare industry is highly… more
- Veterans Affairs, Veterans Health Administration (Palo Alto, CA)
- …Veterans Integrated Services Network Advisory Board, Clinical Product Review, Reusable Medical Device , Environment of Care Rounds, and Enterprise Equipment ... outcomes. Provides health system-wide leadership for critical and semi-critical Reusable Medical Device (RDM), including sterile storage, reprocessing, standard… more
- Abbott (San Diego, CA)
- …debuggers, unit test frameworks) + Knowledge of design controls and regulations for medical device development is a plus + Understanding of quality software ... visual modeling, multi-threading, formal development methodologies, and source code management + Medical device product development knowledge is a plus + Ability… more
- Terumo Neuro (Aliso Viejo, CA)
- …minimum of eight (8) years of professional experience in a manufacturing setting within the medical device industry or similar field. 3. A minimum of two (2) ... large production team to achieve key goals for safety, compliance , and output. Job duties: + Direct a team...to analyze data/metrics and propose solutions. 4. Knowledge of medical device production equipment. 5. Experience with… more
- Medtronic (Northridge, CA)
- …teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also supports product development by designing ... + Provide technical documentation supporting biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical… more
- Mentor Technical Group (Millbrae, CA)
- …knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... or equipment maintenance role in a regulated industry (pharmaceutical, biotech, or medical device preferred). + EPA Universal Certification (Section 608). +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/ compliance /posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND ... accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …targets and expectations. + 3 years' experience leading operations within a dental device or medical device (FDA regulated industry) environment strongly ... directing work; appraising performance; rewarding and disciplining employees; addressing compliance and solving problems. **Job Requirements:** + Bachelor's degree… more
- Hologic (San Diego, CA)
- …environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE ... team member on New Product Development projects to ensure compliance with design controls, as well as identify and...mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management… more
- J&J Family of Companies (Irvine, CA)
- …experience in Customer Support, Sales Support, or Program Management-ideally in the medical device , life sciences, or regulated industries. Demonstrated ability ... and execution within approved guidelines. For competitive trade-in programs, ensure compliance tracking and reporting in accordance with established policies and… more