Stefanini, Inc
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Principal Software Quality Engineer – Bellevue, WA (Hybrid, 5 months, Contract to Perm, 1st Shift, 8:00 AM – 5:00 PM PST)
Job Details Posted: 10/13/2025 | Job ID: 61897 | Location: Bellevue, WA | Work Location: Hybrid (Local candidate preferred)
Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams; lead design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members to optimize success of development projects.
Lead development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEA, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation; oversee product development plans and design inputs/outputs.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality; collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support successful transfer and hyper‑care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities) encountered in production and development projects; guide triage and remediation efforts.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own resolution and timely closure of CAPAs related to the design control process.
Provide support for released products, interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
B.S./M.S. in a relevant engineering field (e.g., biomedical, software, electrical) or equivalent scientific degree.
8+ years of progressive Quality Engineering experience in the medical device industry with hands‑on support for hardware and software development.
Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non‑embedded software.
Experience in deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Must be comfortable working in a high‑growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Certified ASQ CQE, Six Sigma Black Belt/Green Belt preferred; experience with AI, SaMD, cloud infrastructure, and AAMI TIR45 framework preferred.
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives.
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Job Details Posted: 10/13/2025 | Job ID: 61897 | Location: Bellevue, WA | Work Location: Hybrid (Local candidate preferred)
Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams; lead design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members to optimize success of development projects.
Lead development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEA, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation; oversee product development plans and design inputs/outputs.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality; collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support successful transfer and hyper‑care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities) encountered in production and development projects; guide triage and remediation efforts.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own resolution and timely closure of CAPAs related to the design control process.
Provide support for released products, interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
B.S./M.S. in a relevant engineering field (e.g., biomedical, software, electrical) or equivalent scientific degree.
8+ years of progressive Quality Engineering experience in the medical device industry with hands‑on support for hardware and software development.
Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non‑embedded software.
Experience in deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Must be comfortable working in a high‑growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Certified ASQ CQE, Six Sigma Black Belt/Green Belt preferred; experience with AI, SaMD, cloud infrastructure, and AAMI TIR45 framework preferred.
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives.
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