- BD (Becton, Dickinson and Company) (Brea, CA)
- …and medical device CAPA process. + Experience in medical device product development and application of Design Controls. + Strong understanding of ... **Job Description Summary** Sr Design Quality Systems Manager reports to...a design center. **Knowledge and Skills:** + Quality Management Systems requirements for medical devices… more
- Hologic (San Diego, CA)
- …experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR ... of Sure to life. We are hiring for a Quality Engineer in our Design Quality...mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management… more
- Actalent (Irvine, CA)
- …with our medical devices. The ideal candidate will have strong experience in quality systems within the medical device industry and a proven ability ... guidance to internal stakeholders on claim substantiation processes. + Design and deliver training sessions for key stakeholders on... Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and training development, and summative usability studies. + Author HFE deliverables for device design history files and HFE sections for health authority ... human factors engineering (HFE) strategies and HFE activities for device combination product design and development from...required. + Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms.… more
- SanDisk (Milpitas, CA)
- …portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as ... power, and endurance at a lower cost without forgoing quality . The Memory Technology organization is a strategic entity...Engineer to lead and deliver projects for our Memory Design team. This is a great opportunity for a… more
- Philips (San Diego, CA)
- …+ You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design ... + You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing software defects, … more
- Imperative Care (Campbell, CA)
- …Process Validation principles. + Ability to comprehend principles of engineering, physiology, and medical device use Employee Benefits include a stake in our ... training to the QA department on statistical analysis, experimental design , and other quality assurance topics. +...or Lean). + Strong knowledge of FDA requirements for design control of medical devices and 21… more
- SanDisk (Milpitas, CA)
- …more of the following areas: system validation, system integration, software development, NAND device , storage device design and testing, failure analysis, ... portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as… more
- SanDisk (Milpitas, CA)
- …portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as ... at Sandisk: **Essential duties and responsibilities:** + **AI-Enhanced Chip Design ** - Design Engineers will be responsible...scripting (eg, Python, Perl, TCL) and an understanding of device physics in deep sub-micron technologies are a plus.… more
- SanDisk (Milpitas, CA)
- …portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as ... power, and endurance at a lower cost but on quality . The Memory Technology organization is a strategic entity...for you. ESSENTIAL DUTIES AND RESPONSIBILITIES: + Architect and design circuits at transistor level and gate level for… more