Work Flexibility: Hybrid
Stryker is hiring a
Senior Engineer, Advanced Quality, for our
Sustainability Solutionsteam in
Tempe, Arizona supporting our reprocessing product line. In this role, you'll be part of a team that ensures innovative medical devices are safe, effective, and compliant. You'll collaborate across R&D, Regulatory Affairs, and Operations to deliver products that improve patient outcomes worldwide. If you're passionate about quality and innovation, this is your chance to make a real impact.
What You Will Do- Represent Quality Assurance on cross-functional New Product Development teams to meet project milestones.
- Lead Risk Management activities, including creating and maintaining Risk Management Files and ensuring compliance with design control procedures.
- Plan, design, and implement inspection and testing methods using advanced statistical techniques to ensure product reliability.
- Conduct and lead Design Reviews to confirm design robustness and regulatory compliance (QSR, ISO 13485).
- Perform and review engineering risk analyses, test methods, and process improvements to enhance quality and efficiency.
- Guide product development by interpreting test data and developing protocols for processes and products.
- Mentor junior team members and lead departmental initiatives to drive quality and compliance.
- Collaborate with internal teams and customers to address product quality concerns and support continuous improvement.
What You Will NeedRequired Qualifications- Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, Biomedical Engineering or related field.
- 2+ years of experience in an engineering role.
Preferred Qualifications- Experience in data collection, data analysis, and applying scientific methods.
- Experience with Quality concepts such as Risk Management, CAPA, Audits, and Statistics.
- Previous experience in the medical device industry.
- Knowledge of U.S. and international medical device regulations, including ISO 13485, GDP, and GMP.
- Six Sigma Green Belt or ASQ Certified Quality Engineer (CQE).
USN: $77,700 - $129,500 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%
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.
