Experis
Senior Principal Software Quality Engineer
Our client is seeking a dedicated and experienced Senior Principal Software Quality Engineer to join their dynamic team. As a Senior Principal Software Quality Engineer, you will be an integral part of the Quality Engineering department supporting hardware and software development teams. The ideal candidate will demonstrate strong leadership, meticulous attention to detail, and excellent communication skills, which will align successfully within the organization.
Location: Bellevue, WA. Hybrid preferred; however, open to fully remote candidates who are able to travel to the site on occasion.
What’s the Job?
Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with industry standards and regulations.
Lead the development and maintenance of the Risk Management File (RMF), including risk management plans, hazards analysis, and FMEAs.
Review and approve Design History Files (DHF), product development plans, design inputs and outputs, verification, validation, and associated documentation.
Serve as the Subject Matter Expert (SME) for software quality, collaborating on code reviews, security analysis, and software BOM management.
Support the transfer and deployment of products into production, providing quality oversight and addressing anomalies such as bugs and cybersecurity vulnerabilities.
What’s Needed?
8+ years of progressive Quality Engineering experience in the Medical Device industry, supporting hardware and software development.
Deep understanding of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366 standards.
Experience with design, verification, validation, and testing of electromechanical medical devices and embedded/non-embedded software.
Proficiency in statistical tools, data analysis techniques, and quality engineering tools for process improvement.
Exceptional verbal and written communication skills, with the ability to manage multiple projects independently.
What’s in it for me?
Opportunity to work with innovative medical technologies in a high-growth environment.
Collaborate with a diverse and talented team committed to excellence and quality.
Engage in meaningful work that impacts patient care and safety.
Flexible work arrangements to support work-life balance.
Potential for contract extension or permanent conversion based on performance.
If this role interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
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Location: Bellevue, WA. Hybrid preferred; however, open to fully remote candidates who are able to travel to the site on occasion.
What’s the Job?
Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with industry standards and regulations.
Lead the development and maintenance of the Risk Management File (RMF), including risk management plans, hazards analysis, and FMEAs.
Review and approve Design History Files (DHF), product development plans, design inputs and outputs, verification, validation, and associated documentation.
Serve as the Subject Matter Expert (SME) for software quality, collaborating on code reviews, security analysis, and software BOM management.
Support the transfer and deployment of products into production, providing quality oversight and addressing anomalies such as bugs and cybersecurity vulnerabilities.
What’s Needed?
8+ years of progressive Quality Engineering experience in the Medical Device industry, supporting hardware and software development.
Deep understanding of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366 standards.
Experience with design, verification, validation, and testing of electromechanical medical devices and embedded/non-embedded software.
Proficiency in statistical tools, data analysis techniques, and quality engineering tools for process improvement.
Exceptional verbal and written communication skills, with the ability to manage multiple projects independently.
What’s in it for me?
Opportunity to work with innovative medical technologies in a high-growth environment.
Collaborate with a diverse and talented team committed to excellence and quality.
Engage in meaningful work that impacts patient care and safety.
Flexible work arrangements to support work-life balance.
Potential for contract extension or permanent conversion based on performance.
If this role interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
#J-18808-Ljbffr