Manufacturing Engineer (Onsite - Acton, MA)
About The Position
The Manufacturing Engineer performs engineering work to plan, devise, or adapt methods that improve process effectiveness at captive and third-party manufacturing sites. The role examines components, equipment, processes, operations, and finished device designs to identify opportunities for improvement. The engineer maintains a cGMP-compliant environment and operates within FDA guidelines for Class II medical device manufacturing. The role supports product and process improvements, validation and qualification activities, engineering change orders, manufacturing fixture design and construction, and projects from concept through implementation and ongoing manufacturing support.
Requirements
- Bachelor of Science in an engineering discipline, or an equivalent combination of education and experience.
- 3–5 years of work experience in a manufacturing environment.
- Effective verbal and written communication skills.
- Ability to organize and judge priorities.
- Ability to generate and maintain accurate records.
- Ability to work well in a team environment and take personal ownership of projects as needed.
- Strong computer skills, including MS Office, MS Project, and Statgraphics.
Nice To Haves
- Experience in the medical device industry.
- Knowledge of manufacturing processes such as injection molding, metal stamping or forming, PCB manufacture, manual and automated assembly, decorating, extrusion, and ultrasonic welding.
- CAD experience with ProEngineer or Solidworks.
Responsibilities
- Maintain a cGMP-compliant environment and operate within FDA guidelines for Class II medical device manufacturing.
- Drive product and process improvements in support of Insulet’s CAPA system.
- Generate validation and qualification protocols, coordinate their execution, and write final reports.
- Author and implement Engineering Change Orders.
- Design and coordinate the construction of manufacturing fixtures.
- Support all project phases, including concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and ongoing support.
- Perform other duties as assigned.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Employee wellness programs
- May be eligible for incentive compensation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
