Senior Design Quality Engineer; Hybrid

Senior Design Quality Engineer

Redmond, WA

As a Senior Design Quality Engineer, you’ll play a critical role in ensuring our innovative products meet the highest standards of safety and performance. This is your opportunity to influence product development from concept through launch and beyond, driving quality that improves patient outcomes worldwide.

Hybrid – must reside within a commutable distance to Redmond, WA and work onsite several times per week.

• Partner with cross-functional teams to integrate quality requirements into new product development processes.
• Lead product safety risk management activities, including hazard analysis, DFMEA, and risk assessments for distributed products.
• Develop and approve validation strategies, plans, protocols, and reports to ensure compliance with design validation policies.
• Optimize test plans, methods, and sampling strategies to meet regulatory and quality standards.
• Establish and monitor field performance metrics post-launch; analyze trends and recommend improvements.
• Drive timely resolution of quality issues, serving as a key contributor in CAPA investigations and risk management activities.
• Participate in internal and external audits, providing expertise on design controls and product development processes.
• Lead initiatives to improve quality systems and processes across the organization.

• Bachelor’s degree in Engineering, Science, or a related field.
• 2+ years of experience in a highly regulated environment (quality, manufacturing, or engineering).
• Demonstrated experience contributing to a design development project

• Bachelor’s degree in Biomedical Engineering
• Prior experience with electromechanical design and embedded software in product development.
• Knowledge of medical device industry regulations and standards.
• Familiarity with quality tools such as root cause analysis, sampling plans, and validation testing.
• Understanding of good design practices, specification development, and industry standards.

$89,400- $148,900 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.