Senior Engineer – Product Engineering

Job Description

Senior Engineer – Product Engineering

Phoenix, AZ

This position focuses on sustaining engineering activities that enhance product performance, quality, manufacturability, and regulatory compliance. Working across cross-functional teams, you will investigate product issues, implement design and process improvements, and help ensure products continue to meet customer and business needs.

Work Flexibility

Hybrid: candidates must reside within commuting distance of Phoenix, AZ and be able to work onsite several days per week.

What You Will Do

• 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.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives.

Preferred Qualifications

• Knowledge of medical device regulations, including design control requirements and regulatory submissions.
• Experience supporting complaint investigations, corrective and preventive actions (CAPA), or post-market product support.
• Experience with statistical analysis and data-driven problem solving.

Salary

• $77,700 – $129,500 USD Annual