Senior Manufacturing Engineer

Responsibilities

• Drive product and process improvements to optimize quality, efficiency, and cost
• Manage project deliverables for the installation and upgrade of new manufacturing equipment
• Support equipment validation activities, including generating and executing IQ, OQ, TMV, CSV, and PQ protocols
• Monitor and report on key performance indicators (KPIs) such as yield and equipment up-time
• Conduct root cause investigations using structured problem-solving tools to address non-conforming materials
• Implement corrective and preventive actions (CAPA) within a cGMP compliant environment
• Author and review quality system documentation, including work instructions, SOPs, and Engineering Change Orders
• Support new product introduction (NPI) initiatives and travel to suppliers for critical investigations

Requirements

• BS in Mechanical, Industrial, or Electrical Engineering with 5+ years of manufacturing experience
• Experience in the medical device industry preferred
• Proficiency in Microsoft Office, specifically advanced Excel and data analysis
• Working knowledge of Minitab or JMP statistical analysis software
• Proficiency in Solidworks and ability to read technical prints
• Strong understanding of Six Sigma and Lean manufacturing concepts
• Ability to travel 30-40% (primarily international)
• Ability to work in a Class 8 Cleanroom environment

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• Employee wellness programs

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. Headquartered in Massachusetts, Insulet develops wearable, tubeless insulin delivery systems that empower users to manage their health with ease and flexibility.