Ecocareers · 2 months ago
Sr. Principal Software Quality Engineer
Bellevue, WA
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expBaxter is seeking a Sr. Principal Software Quality Engineer who will provide technical leadership for product quality, design control, risk management, and software quality assurance activities. This role involves overseeing quality engineering for both hardware and software development, ensuring compliance with regulations, and guiding product development teams.
Staffing & Recruiting
Responsibilities
Provide Quality Engineering leadership to product development teams for both hardware and software
Lead Design Control and Risk Management activities (plans, hazard analyses, dFMEA/pFMEA, RMF reports)
Oversee and approve Design History File (DHF) documentation, including design inputs/outputs, V&V, and test planning/protocols
Serve as Software Quality SME — guiding code reviews, software security analysis, and software BOM
Lead implementation of software quality best practices and compliance processes
Support transfer to manufacturing, ensuring product quality continuity during launch and field deployment
Provide quality oversight and guide resolution of software bugs, anomalies, and cybersecurity vulnerabilities
Implement Quality System updates based on new regulations or standards
Lead CAPA resolution and closure related to design control processes
Support released products and collaborated with customer support as needed
Contribute to continuous process improvement and other QA initiatives as directed by management
Qualification
Required
B.S./M.S. in Engineering (Biomedical, Software, Electrical, or related field) or equivalent scientific discipline
8+ years of progressive Quality Engineering experience in the medical device industry
Strong working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366
Hands-on experience with hardware/software design, verification, validation, and electromechanical device testing
Expertise in statistical tools and data analysis (e.g., Minitab)
Proven ability to manage multiple projects and drive quality and compliance culture
ASQ CQE and/or Six Sigma (Black/Green Belt) certification
Experience with AI/ML, AAMI TIR45, SaMD, and cloud infrastructure quality systems
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase