- 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
- 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 (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
- Amazon (El Segundo, CA)
- …satellite communications technology to make global connectivity a reality. As a Senior Device Software Development Engineer on the Amazon Leo Government (ALG) ... Mentor junior engineers, conduct design reviews, and uphold high software quality standards. Security Clearance : This...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
- 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
- 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
- Oracle (Sacramento, CA)
- …as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU ... success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with… more
- Amazon (Sunnyvale, CA)
- …team invents ways to help customers develop complex applications deployed on multiple device types. Developer experience ensures the software product is fully ... Description The Amazon Devices org designs and engineers high-profile consumer electronics,...execution for the key rendering stack components across multiple Device OS programs. You will engage with senior product… more