Senior Engineer, Advanced Quality Engineering

Stryker is hiring a Senior 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 Need

Required 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).