- US Tech Solutions (San Bruno, CA)
- … software development for medical devices , specifically focusing on Software as a Medical Device (SClient) or low-risk enforcement discretion ... support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1.... software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience… more
- J&J Family of Companies (Santa Clara, CA)
- …to improve patient outcomes and advance medical professionals' skills. The Senior Software Quality Engineer is responsible for supporting product quality ... Device Regulation (MDR), and applicable guidance. + Provide Quality representation during software problem resolution. +...verification and validation. + 3 years' experience in a quality role within the medical device… more
- Oracle (Sacramento, CA)
- …compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical device software standards including IEC 62304 ( software ... software architecture and compliance framework for regulated medical devices . This role bridges product development,...of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and… more
- Amazon (Northridge, CA)
- …of satellite communications technology to make global connectivity a reality. As a Device Software Development Engineer on the Amazon Leo for Government (ALG)'s ... Mentor junior engineers, conduct design reviews, and uphold high software quality standards. This position requires that...scalable solutions for custom satellite and ground applications. ALG Device Software focuses on embedded software… more
- Amazon (Northridge, CA)
- …of satellite communications technology to make global connectivity a reality. As an Device Software Development Engineer on the Amazon Leo Government (ALG) team, ... Mentor junior engineers, conduct design reviews, and uphold high software quality standards. This position requires that...scalable solutions for custom satellite and ground applications. ALG Device Software focuses on embedded software… more
- Amazon (Sunnyvale, CA)
- …of satellite communications technology to make global connectivity a reality. As a Device Software Development Engineer on the Amazon Leo for Government (ALG) ... Mentor junior engineers, conduct design reviews, and uphold high software quality standards This position requires that...scalable solutions for custom satellite and ground applications. ALG Device Software focuses on embedded software… more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...* Prefer at least three years of experience in medical devices , ideally class II devices… more
- US Tech Solutions (San Bruno, CA)
- … Medical Device Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management Systems (QMS). + 3+ years of technical ... align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification,… more
- ManpowerGroup (Pleasanton, CA)
- …tools for requirements management and test documentation **Qualifications** + Prior experience in medical device software development + Strong background in ... **Job Title:** Software Engineer ( Medical Devices )/...a mid-level Software Engineer with experience in medical device R&D to support application … more
- Oracle (Sacramento, CA)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical … more
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