- Fujifilm (Sacramento, CA)
- …Technical Assistance Center (TAC). + Participate in Clinical Validations Testing for each software release of the product to further enhance the overall accuracy of ... with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard...+ Proven experience in related field. + Healthcare or software application or IT industry background a plus. +… more
- Abbott (Alameda, CA)
- …of service. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... + 6 years of experience working with Supply Chain software + Experience with global supply chain teams including...+ **Technical Proficiency** : Proficiency in supply chain management software and tools, SAP knowledge is a plus. +… more
- J&J Family of Companies (Santa Clara, CA)
- …Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. **Requirements** + Master's degree ... etc.) + Experience in using CAD/FEA/CFD modeling and analysis software (Ansys) + Experience with CAD software ...analysis software (Ansys) + Experience with CAD software (ie Solidworks) + Experience with statistical analysis and… more
- Hologic (Santa Clara, CA)
- …networking administration + Microsoft Windows and Linux operating systems + Software application testing and maintenance + Cybersecurity Risk Assessment + ... and familiarity with medical device security standards and regulations (eg, FDA Premarket Cybersecurity Guidance, IEC 81001-5-1, AAMI TIR57, AAMI SW96). +… more
- J&J Family of Companies (Santa Clara, CA)
- …Function:** Technology Product & Platform Management **Job Sub** **Function:** Software Engineering - Full Stack **Job Category:** Scientific/Technology **All Job ... Engineer to join a team of hardworking roboticists and software engineers who are trying to seek some of...open-source community and development concepts. + Experience in an FDA regulated field (Med Device/Pharma) is a strong plus.… more
- J&J Family of Companies (Santa Clara, CA)
- …of and compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD and other applicable regulations. + Experience and understanding Process ... PQ), 6S, Lean Manufacturing + Experience applying statistics and using statistical software , running Capability Studies (Cpk's), and planning and analyzing DOE's. +… more
- Abbott (Pleasanton, CA)
- …property. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... Leads systems engineering efforts. **Required Qualifications** + Bachelor's degree in software engineering, computer science, or a related engineering field. +… more
- Amgen (Thousand Oaks, CA)
- …priorities in a very dynamic environment + Experience in project management and FDA type Quality Management Systems + Ability to lead projects independently and take ... ability to work in a team environment + Familiarity with the following programs/ software : SAP Arriba, Trackwise, Minitab, MS Office (Visio, Excel, Word, PPT), CDOCS,… more
- Abbott (Alameda, CA)
- …in the integration of analytical and performance-related elements with software , hardware, and electronics system components. **QUALIFICATIONS** + Bachelor's degree ... with system identification/stochastic modeling and algorithm development for sensor systems through FDA clearance or approval. **Preferred** + A master's degree or a… more
- University of Southern California (San Diego, CA)
- …preferred + A minimum of 2 years experience working with TMF and/or eTMF system software + Strong knowledge of ICH-GCP and CFR 21 + Monitoring or Quality Assurance ... experience is required + Thorough understanding of records management requirements in FDA regulated trials + Ability to build and maintain positive relationships… more