Senior Sustaining Engineer – Medical Devices

Stryker Group; Phoenix (AZ); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Onsite several days per week

Job summary

Stryker Group in Phoenix, AZ is seeking a Senior Engineer - Product Engineering to sustain and enhance medical devices. You will lead design changes, perform investigations, and drive CAPA, risk management, and validation activities within a cross-functional team.

Hybrid work arrangement with onsite presence several days per week is expected. The role focuses on improving product quality, reliability and regulatory compliance through data-driven engineering and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering or related field.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives.
• Knowledge of medical device regulations, including design control and regulatory submissions.
• Experience with CAPA and post-market product support.

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

Statistical analysis

CAPA / quality improvement

Education

Bachelor's degree in Mechanical/Electrical/Biomedical Engineering

Job description

Stryker Group in Phoenix, AZ is seeking a Senior Engineer - Product Engineering to sustain and enhance medical devices. You will lead design changes, perform investigations, and drive CAPA, risk management, and validation activities within a cross-functional team.

Hybrid work arrangement with onsite presence several days per week is expected. The role focuses on improving product quality, reliability and regulatory compliance through data-driven engineering and continuous improvement initiatives.