As a Senior Design Quality Engineer, you will ensure product quality, manage risk assessment, lead audits, and drive quality system improvements.
Work Flexibility: 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.
Work Flexibility:
Hybrid – must reside within a commutable distance to Redmond, WA and work onsite several times per week.
What You Will Do
- 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.
What You Will Need
Required Qualifications
- 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
Preferred Qualifications
- 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.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Top Skills
Quality Tools
Root Cause Analysis
Sampling Plans
Validation Testing
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