Sr. Principal Engineer

Job DescriptionJob Descriptionn

Job Title: Senior Principal Quality Engineering Leader – Medical Device R&D

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Duration: 12 Months

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Location: Bellevue WA 98005

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Role & Responsibilities:

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Provide Quality Engineering leadership for software and hardware product development teams.

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Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.

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Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.

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Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.

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Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation.

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Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.

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Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.

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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.

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Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.

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Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.

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Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects.

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Guide triage and remediation efforts.

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Secondary/Backup Duties and Responsibilities:

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• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.

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• Own the resolution and timely closure of CAPAs as they relate to the design control process.

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• Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.

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• Support other areas of the Quality System and perform other tasks as defined by Management.

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Required Qualifications, Education and Experience:

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

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• 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.

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Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.

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• Exceptional verbal and written communication skills and presentation skills.

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• Exceptional attention to detail with the proven ability to wear many hats.

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• Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.

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• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.

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• Creative problem solver.

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• Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.

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Additional Qualifications:

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• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt .

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• Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is .

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• Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is .

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

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• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.

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Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.
Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilitiesCompany DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.rnrnBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities