Senior Engineer - Product Engineering
About the role
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.
What You Will Need
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.
- $77,700 - $129,500 USD Annual
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