- Actalent (Vista, CA)
- …annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or FDA. + Review regulatory ... + Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and...of related experience and/or training or equivalent combination of education and experience. + Knowledge of Database Software (EPDM),… more
- Medtronic (Irvine, CA)
- …+ Maintain up-to-date knowledge of cybersecurity regulations and standards specific to the medical device industry (FDA, HIPAA, IEC 62443, NIST, NIS 2, etc.). ... GRC (Governance, Risk, & Compliance), or external/internal audit, preferably within the medical device or healthcare industry. + Strong understanding of… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …with Current Good Manufacturing Practices (cGMP) + Maintains detailed and accurate device history records and log books using Good Documentation Practices (GDP) + ... Completes and forwards device history records for review in a timely manner...with cross-functional partners (eg, Supply Chain, Manufacturing Sciences, Warehouse) ** Education :** Typically requires an Associate's or Bachelor's degree in… more
- Cordis (Irvine, CA)
- …up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to ... Engineering, Biomedical Engineering, or a related Engineering field. + 5+ years in medical device production development + Previous experience working in a… more
- Abbott (Milpitas, CA)
- …engineering field. + 10-15 years of management and technical management experience in the medical device industry with minimum 5 years at a senior management ... error analysis, usability and validation testing. + Extensive knowledge of entire medical device development process from needs definition through regulatory… more
- Actalent (Los Angeles, CA)
- …EDC (Electronic Data Capture) data entry and management + Assist patients with Day 1 device setup + Provide patient education on wearable device usage + ... support a clinical trial focused on hypertension and wearable medical devices. This role is ideal for someone with...to adhere to a structured schedule + Clear and professional communication skills Pay and Benefits The pay range… more
- US Tech Solutions (South San Francisco, CA)
- …(EDC) systems for clinical studies. **Desired:** + Desired Experience with digital medical device research studies. + Experience maintaining an Electronic Trial ... Conduct Clinical Research Coordinator activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining… more
- Imperative Care (Campbell, CA)
- …or master's degree in engineering with 2 years of related experience in the medical device or related regulated industry; or equivalent combination of ... and quantify the physical characteristics and performance of the device by experimental design. Your knowledge of solid mechanics,...education and work experience. + Experience with product testing,… more
- Fotona (San Francisco, CA)
- …skills to break into the lucrative aesthetic laser market. Capital Equipment, Durable Medical Equipment, and/or Medical Device sales experience, high volume ... in outbound business-to-business sales experience preferred. + Capital Equipment, Durable Medical Equipment, and/or Medical Device sales experience… more
- Micron Technology, Inc. (Folsom, CA)
- …scripting language is highly encouraged. + Good understanding of Process Technology and device physics of advanced CMOS device architecture (FinFET and GAA). + ... reliability definition role to meet the product requirements + Understanding of compact device models, aging models and reliability physics is a plus. + Familiarity… more