Senior Quality Engineer

Quality Engineering Leader

220 120th Avenue NE, Bellevue, WA, USA, 98005 (3 Days Onsite)

Summary: 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.

Main Duties and Responsibilities:

• Provide Quality Engineering leadership for software and hardware product development teams.
• Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
• Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation.
• Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
• Serve as the SME for software quality and 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 the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
• Support the 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, etc.) encountered in production and development projects. Guide triage and remediation efforts.

Secondary/Backup Duties and Responsibilities:

• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
• Own the resolution and timely closure of CAPAs as they relate to the design control process.
• Provide Quality Engineering 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:

• Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
• Experience in the 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 the 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.

Additional Qualifications:

• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
• Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
• Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.

Education and Experience:

• 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.

Physical Demands and Work Environment:

• Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment

Skill matrix Mandatory Skills Years of Experience Year Last Used Rating Out of 10 QA for medical device hardware and Software medical device industry Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366