Job Description

Senior Quality Engineer - New Product Introduction
Redmond, WA

Join a team that brings life‑changing medical technologies from concept to patients around the world. As a Senior Quality Engineer - NPI, you will play a critical role in ensuring new products and processes are designed, transferred, and launched with the highest standards of quality and reliability. This is an exciting opportunity to influence how products are built, validated, and scaled - right from the start.

What You Will Do

• Execute quality assurance activities during design transfer to ensure new products and processes meet defined quality, regulatory, and manufacturing requirements.
• Evaluate and mitigate manufacturing and process risks by developing and maintaining robust process Failure Modes and Effects Analyses across the full manufacturing lifecycle.
• Develop and implement efficient inspection strategies, including sampling plans, First Article Inspection approaches, and measurement system analysis to ensure repeatable and scalable inspections.
• Support and approve validation activities by contributing to the development, execution, and review of validation protocols and reports, including sterilization validation where required.
• Apply statistical and risk‑based techniques to build predictive, transferable quality systems that support stable production and successful launches.
• Support nonconformance and corrective and preventive action activities related to new products, ensuring timely root cause analysis and sustainable solutions.
• Partner with supplier quality and sourcing teams to support supplier selection, qualification, validation, and production part approval activities.
• Represent quality assurance in design reviews and design transfer planning, ensuring lessons learned are captured and transferred to sustaining quality teams post‑launch.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• 2+ years of experience in a regulated manufacturing environment.
• Experience supporting quality activities for new product or process introductions.
• Proficiency in risk‑based and statistical quality techniques, including process risk analysis, sampling plans, process capability, and measurement system analysis.

Preferred Qualifications

• Certification as a Certified Quality Engineer or equivalent coursework or experience.
• Working knowledge of quality system regulations and standards such as ISO 13485 and FDA Quality System Regulation.
• Lean Six Sigma training or certification.
• Experience with medical device manufacturing processes and validation activities.

$77,700.00 - 168,400.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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