- Abbott (Santa Clara, CA)
- …by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... Opportunity** The ** Senior Manager Regulatory Affairs** will work for our Global...and leadership on regulatory activities and works with the medical device business units that Leverage Services… more
- Gilead Sciences, Inc. (La Verne, CA)
- …provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system (QMS) ... + Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations + Participate in the… more
- Abbott (Alameda, CA)
- …development is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA) is desirable. + ... preferred + Embedded UI design experience preferred + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement… more
- Abbott (Santa Clara, CA)
- …providing engineering expertise in its creation and the development of this class 3 medical device product in this desirable technology space. Hiring Manager - ... treating structural heart disease. We are recruiting for a Senior Staff R&D Engineer to join our Ventures organization...education and work experience. + Minimum 10 years in medical device development and/or other highly regulated… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... and ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if components, sub-assemblies, products meet specification… more
- Medtronic (Northridge, CA)
- …management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This role involves conducting comprehensive ... connected, compassionate world. **A Day in the Life** The Senior Product Engineer is responsible for leading biological evaluations...preferred. + Strong understanding of ISO 10993 and global medical device regulations (eg, EU MDR, FDA,… more
- Abbott (Alameda, CA)
- …discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- ZOLL Medical Corporation (Irvine, CA)
- …plus + Experience with current unit test frameworks is a plus + Experience with medical device development is helpful but not required Please note this job ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...have a job. You'll have a career-and a purpose. Senior Software Engineer - Embedded Job Summary: We are… more
- Abbott (Alameda, CA)
- …and work experience + Minimum 10 years of related work experience with medical device product development + Has successfully led several high complexity ... Qualifications:** + Experience designing and implementing design control tools within medical device industry. + Require strong technical experience in… more
- Stryker (San Jose, CA)
- …Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to ... or similar, demonstrating strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD),… more