Senior Engineer, Advanced Quality Engineering
Stryker
Summary
Stryker is hiring a Senior Engineer, Advanced Quality for our Sustainability Solutions team 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.
Job description
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.
Required 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).
Requirements
- 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
- 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)
Benefits
- Hybrid Work Flexibility
- Medical, Dental & Vision
- 401(k) Matching
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.