USA - Sr. Principal Engineer
Robert HalfBellevue, WA, US23 days ago
Job type
- Full-time
Job descriptionContract with possibility of extension Temp-to-hire potential Lead design control, risk management, and other quality engineering activities for new product development. Develop and maintain Risk Management Files (RMF) : risk plans, hazard analysis, dFMEAs, pFMEAs, and reports. Review and approve Design History File (DHF) documentation. Oversee product development plans, design inputs / outputs, verification / validation, and test protocols / reports. Guide statistical methods and analyses for design verification and validation. Act as SME for software quality : code reviews, software security analysis, software BOM, and best practices. Participate in design reviews for hardware / software lifecycle management. Support production transfer and post-deployment phases. Address anomalies (e.g., bugs, cybersecurity issues) and guide remediation. Lead updates to the Quality System based on new regulations and standards. Own CAPA resolution related to design control. Support released products and interface with customer support. Assist other Quality System areas as needed. 8+ years of progressive Quality Engineering experience in the medical device industry . Hands-on support for hardware and software development . Strong knowledge of : FDA CFR 820 ISO 13485, ISO 14971 IEC 60601 series, IEC 62304, IEC 62366 Experience with : Design, development, verification, validation, and testing of medical devices Statistical tools and data analysis Excellent communication and presentation skills Ability to manage multiple projects and advocate for quality Proficient in Microsoft Office, Adobe Acrobat, Minitab, and other business software ASQ CQE certification and / or Six Sigma Black Belt / Green Belt Experience with : Artificial Intelligence (AI) and AAMI TIR45 framework Software as a Medical Device (SaMD) Cloud infrastructure B.S. / M.S. in Engineering (Biomedical, Software, Electrical, etc.) or equivalent scientific degree
Job Description
Job Description
Join a high-impact team driving innovation in medical device development—where your expertise in software and hardware quality engineering will directly shape the future of healthcare technology.
Schedule & Location :
- Hours : 8 : 00 AM – 5 : 00 PM (Pacific Time)
- Work Setup : Hybrid preferred (3 days / week onsite or as needed)
- Local candidates preferred
- Open to remote with occasional travel to site
Employment Type :
Job Description
Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with regulatory standards and driving quality throughout the product lifecycle.
Essential Duties & Responsibilities
Primary Responsibilities :
Secondary / Backup Responsibilities :
Qualifications
Required :
Preferred :
Education :
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Sr Principal Engineer • Bellevue, WA, US
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