Associate Manufacturing Engineer (Onsite - Acton) (Medical Device Manufacturing)

Location: Onsite at the Acton, Massachusetts, United States manufacturing facility; approximately 5% travel to key suppliers, with travel varying according to business needs.

Annual base salary: $65,100–$97,650 USD. The role may also be eligible for incentive compensation.

Company

Medical device manufacturer developing the Omnipod wearable insulin delivery platform and related drug-delivery technologies.

What you will do

• Support installation, specification, project management, training, qualification, implementation, and production support for new manufacturing equipment.
• Coordinate with equipment suppliers, contract manufacturers, and internal teams to meet project performance, timing, and budget targets.
• Generate and execute validation and qualification protocols, including OQ, TMV, CSV, and PQ, and prepare final reports.
• Drive continuous improvement, new product introduction, corrective and preventive actions, and improvements to quality, efficiency, cost, yield, and equipment uptime.
• Investigate non-conforming materials and manufacturing issues using structured root-cause and problem-solving tools; author engineering change orders and quality-system documentation.
• Design and coordinate manufacturing fixtures, perform mechanical analyses and material evaluations, and support equipment and process investigations at supplier sites.

Requirements

• High school diploma with 10+ years of practical engineering experience in a highly regulated manufacturing environment, or a B.S. in Mechanical, Industrial, or Electrical Engineering (or equivalent) with 0–2 years of manufacturing engineering experience.
• Proficiency with Microsoft Office, including excellent Microsoft Excel and data-analysis skills.
• Working knowledge of Minitab and/or JMP statistical analysis software.
• Working knowledge of SolidWorks and engineering print reading.
• Proficiency in Lean manufacturing and Six Sigma concepts.
• Ability to troubleshoot semi-automated and fully automated mechanical equipment.
• Basic knowledge of assembly challenges involving molded components, stamped metal, and springs.
• Strong command of structured problem-solving tools and strong project-management skills.
• Ability to work in a cGMP-compliant, FDA-regulated Class II medical device manufacturing environment and author or review validations, work instructions, SOPs, non-conforming material investigations, and tool files.

Nice to have

• Experience in the medical device industry.
• High-volume manufacturing and/or automation experience.

Culture & Benefits

• In-person work at the Acton manufacturing facility with collaboration across global manufacturing teams.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and additional employee wellness programs.
• Opportunity to contribute to insulin-delivery products serving patients with diabetes.