Senior Engineer, Advanced Quality Engineering

Senior Engineer,Advanced Quality EngineeringStryker is hiring aSenior Engineer,Advanced Quality, for our Sustainability Solutions team 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.Work Flexibility:• Hybrid; must reside within a commutable distance to Tempe, AZ and be onsite at least 3 days per week. 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. • Experience in data collection, data analysis, and applying scientific methods. Preferred Qualifications• 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). Apply tot his job