Manufacturing Engineer

Responsibilities

• Drive continuous improvement efforts for manufacturing processes and equipment to enhance efficiency, quality, and cost-effectiveness.
• Support manufacturing expansion by managing project deliverables for new equipment installation, upgrades, and component introductions.
• Conduct structured root cause investigations using standardized problem-solving tools and support the CAPA system.
• Develop, execute, and document validation protocols (IQ, OQ, TMV, CSV, PQ) for new and existing processes and equipment.
• Monitor and report on critical performance metrics and KPIs to ensure production targets are met.
• Collaborate cross-functionally with Maintenance, Equipment Design, Controls, Operations, and Quality teams.
• Maintain a cGMP compliant environment in accordance with FDA and ISO guidelines for Class II Medical Device manufacturing.

Requirements

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, or a related field (or equivalent combination of education and experience).
• 3-5 years of experience in a manufacturing environment.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
• Working knowledge of CAD design and print reading (SolidWorks preferred).
• Familiarity with root cause analysis techniques (DMAIC, Fishbone, etc.) and statistical process control (SPC).
• Experience with validation techniques including IQ, OQ, and PQ.
• Ability to work onsite in Acton, MA, with estimated travel of 30-40%.

Preferred Qualifications

• Experience in the medical device industry.
• Experience in high-volume manufacturing or highly automated environments.
• Proficiency with statistical analysis software such as Minitab or JMP.
• Knowledge of manufacturing processes such as injection molding, stamping, CNC milling, or ultrasonic welding.

Benefits

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

About the Company

Insulet is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod® product platform. Our technology provides wearable, waterproof, and lifestyle-accommodating insulin delivery solutions that empower patients to live healthier lives.