Senior Manufacturing Engineer

Responsibilities

• Drive product and process improvements to achieve high quality, high efficiency, and low cost.
• Manage project deliverables for the installation and upgrade of new manufacturing equipment.
• Support all project phases including concept, specification, cost justification, installation, and qualification.
• Monitor and report on yield and equipment up-time KPIs to ensure targets are met.
• Generate and execute validation/qualification protocols (IQ, OQ, TMV, CSV, PQ) and author final reports.
• Conduct root cause investigations using structured problem-solving tools for non-conforming material.
• Implement corrective and preventive actions (CAPA) and author Engineering Change Orders.
• Maintain a cGMP compliant environment in accordance with FDA guidelines for Class II Medical Devices.

Requirements

• BS in Mechanical, Industrial, or Electrical Engineering with 6+ years of medical device experience.
• OR an MS in Engineering or Engineering Management with 5+ years of medical device experience.
• Proficiency in Minitab or JMP statistical analysis software.
• Working knowledge of Solidworks and ability to read technical prints.
• Strong understanding of cGMP and FDA guidelines.
• Ability to work in a Class 8 Cleanroom environment for extended periods in a standing position.
• Ability to travel internationally (up to 5% required).

Preferred Qualifications

• Proficiency in Six Sigma and Lean manufacturing concepts.
• Experience troubleshooting both semi-automated and fully automated mechanical equipment.
• Knowledge of assembly challenges related to molded components, stamped metal, and springs.
• Strong project management and data analysis skills using Microsoft Excel.

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. Our flagship Omnipod Insulin Management System provides a unique, wearable, tubeless alternative to traditional insulin delivery methods.