Position located in Waltham, MA

Responsibilities of the Senior Sustaining Engineer:

• Serve as the next-level of technical support for all product design-related matters related to released manufactured products and purchased components.
• Lead efforts to perform root cause analyses, resolve issues, implement product and manufacturing process changes, modifications, and design enhancements.
• Investigate and resolve corrective and preventative actions using appropriate problem-solving techniques.
• Track product issues, drive effective and swift resolution, and monitor metrics associated with the team’s work.
• Support the implementation and maintenance of processes utilized in internal and external manufacturing, and depot repair and field service activities. Prevent and/or respond to production stoppages due to supplier, process, or quality related matters.
• Lead team efforts aimed toward improving customer satisfaction, product quality improvement, manufacturing yield improvement, reducing product variability, and reducing the cost of goods sold.

Requirements of the Senior Sustaining Engineer:

• Bachelor’s degree (B.S.) from an accredited, four-year university or college in electrical, mechanical, systems, or biomedical engineering, or similar degree.
• 5+ years of sustaining engineering experience in the medical device industry.
• Experience with ISO 13485 and FDA Quality System Regulations.
• Lean Six Sigma training or certification and knowledge of statistical data analysis techniques.