Staff Engineer, Advanced Quality
Stryker
Summary
Stryker is hiring a Staff Advanced Quality Engineer to join our Sustainability Solutions team in Tempe, Arizona. In this role, you will partner with R&D Engineering and Advanced Operations throughout new product development, defining design requirements, developing manufacturing processes, and leading risk management activities to support product and process quality from development through launch.
Job description
What You Will Do
- Develop quality assurance documentation to support new product development and regulatory submissions.
- Lead risk management activities throughout product development, including evaluating residual risk and presenting final risk-benefit justifications to executive leadership.
- Partner with cross-functional teams to define design requirements and verification and validation testing, ensuring objective evidence supports established acceptance criteria.
- Collaborate with Advanced Operations to develop manufacturing processes and support product design transfers to internal and external manufacturing facilities.
- Apply statistical analysis and problem-solving techniques to establish product acceptance limits, define process parameters, analyze critical quality attributes, and resolve quality issues.
- Develop, review, and approve inspection plans, manufacturing documentation, and product drawings for new products.
- Evaluate quality issues from existing products and initial market feedback to identify potential risks and address concerns during new product development.
- Lead quality system improvements and provide technical direction to Quality Engineers and cross-functional project teams throughout design and process development.
What You Will Need
Required Qualifications
- Bachelor’s degree in Mechanical, Electrical, Chemical, Materials Science, Biomedical Engineering, or a related field.
- Minimum 4 years of experience in engineering.
- Experience applying quality concepts including corrective and preventive action (CAPA), audits, and statistical methods.
- Experience applying quality tools and problem-solving methods, such as Failure Mode and Effects Analysis, geometric dimensioning and tolerancing, root cause analysis, or mistake proofing.
Preferred Qualifications
- Master’s degree in an engineering or related technical field.
- Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Six Sigma Green Belt, or Six Sigma Black Belt certification.
- Experience supporting product development in the medical device or another regulated industry, including areas such as risk management or design and process verification and validation.
Requirements
- Bachelor’s degree in Mechanical, Electrical, Chemical, Materials Science, Biomedical Engineering, or a related field.
- Minimum 4 years of experience in engineering.
- Experience applying quality concepts including corrective and preventive action (CAPA), audits, and statistical methods.
- Experience applying quality tools and problem-solving methods, such as Failure Mode and Effects Analysis, geometric dimensioning and tolerancing, root cause analysis, or mistake proofing.
- Master’s degree in an engineering or related technical field.
- Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Six Sigma Green Belt, or Six Sigma Black Belt certification.
- Experience supporting product development in the medical device or another regulated industry, including areas such as risk management or design and process verification and validation.
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.