Senior Manufacturing Engineer (Onsite - Acton, MA)

Job Summary

This Senior Manufacturing Engineer role is responsible for supporting both new manufacturing line/equipment implementation and continuous improvement of existing production processes for Insulet’s Omnipod products. The position focuses on driving manufacturing excellence through improved quality, efficiency, and cost reduction while leading equipment validation, troubleshooting, root cause investigations, and process optimization activities. Working closely with suppliers, contract manufacturers, and cross-functional teams, the engineer will manage projects from concept through production, monitor key performance metrics such as yield and equipment uptime, and ensure compliance with medical device quality and regulatory requirements.

About the Role

The ideal candidate has a strong engineering background, experience in medical device manufacturing, expertise in automation and process improvement, and a passion for solving complex manufacturing challenges in a highly regulated environment.

Responsibilities

• Drive product and process improvements in support of Insulet’s Operations (3) main objectives: Best Quality, Highest Efficiency, Lowest Cost
• Support equipment validation and continuous improvement activities at Insulet manufacturing facilities
• Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support
• Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
• Author and implement Engineering Change Orders
• Up to 5% travel required, ability to travel internationally

Requirements

• BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of medical device experience; preferably in a manufacturing environment
• MS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of medical device experience; preferably in a manufacturing environment

Skills/Competencies

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills
• Working knowledge of Minitab and/or JMP statistical analysis software
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both Semi and fully automated
• Strong command of structured problem-solving tools
• Strong project management skills

Behavioral Competencies

• Decision Making – systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.
• Communication Skills – conveys information effectively, actively listens, resolves conflict constructively.
• Work Organization – takes a structured, economical approach to resources including time, people, money, and equipment.
• Problem Solving – uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.
• Initiative – makes decisions and takes actions appropriately. Willing to take risks as circumstances require.
• Planning Skills – sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.
• Perseverance – achieves objectives by overcoming difficulties through tenacity and resilience.