Sustaining Engineer – Medical Devices, Quality & Regulatory

Stryker; Phoenix (AZ); Hybrid; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Dental insurance

Vision insurance

401(k) plan

Employee Stock Purchase Plan

Job summary

Stryker, located in Phoenix, seeks a sustaining engineer to lead projects that enhance product performance, quality, manufacturability, and regulatory compliance. You will work with cross-functional teams to investigate issues, implement design changes, and ensure products meet customer and business needs.

You will coordinate design controls, risk management, validation, and CAPA activities; apply engineering principles and statistics to analyze data and drive continuous improvement across R&D,

Qualifications

• Minimum 2 years of engineering experience in a regulated industry.
• Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives.

Responsibilities

• Lead and support sustaining engineering projects for released medical devices, including design changes, line extensions, and product improvements.
• Investigate product, process, and packaging issues, identify root causes, and implement corrective and preventive actions.
• Partner with Quality teams to evaluate customer complaints and resolve product performance concerns.
• Coordinate design control, risk management, validation, and regulatory activities associated with product changes.
• Represent Research & Development on continuous improvement initiatives that enhance product quality, reliability, and operational efficiency.
• Conduct engineering studies, testing, and validation activities to support design changes and process improvements.
• Collaborate with Operations, Manufacturing, Quality, Regulatory Affairs, Marketing, Sales, suppliers, and customers to support business objectives.
• Apply statistical analysis and engineering principles to evaluate performance data and support technical decision-making.

Skills

Engineering experience

Root cause analysis

Education

Bachelor's degree in Mechanical/Electrical/Biomedical Engineering or related field

Job description

Stryker, located in Phoenix, seeks a sustaining engineer to lead projects that enhance product performance, quality, manufacturability, and regulatory compliance. You will work with cross-functional teams to investigate issues, implement design changes, and ensure products meet customer and business needs.

You will coordinate design controls, risk management, validation, and CAPA activities; apply engineering principles and statistics to analyze data and drive continuous improvement across R&D,