Manufacturing Engineer (On-site)

$68,100 - $102,300/Yr

Insulet Corporation - Acton, MA

Full-time

Acton, MA

Miscellaneous Manufacturing

About the position

Insulet Corporation, founded in 2000, is dedicated to enhancing the lives of individuals with diabetes through our innovative Omnipod® product platform. Our mission is to provide simplicity, freedom, and healthier living for our customers. Over the past two decades, we have positively impacted the lives of hundreds of thousands of patients by developing wearable, waterproof, and lifestyle-friendly technology. As we continue to grow, we are seeking highly motivated and performance-driven individuals to join our expanding team. We believe that our success is rooted in hiring exceptional people who share our values and are committed to exceeding customer expectations. The position involves performing engineering work focused on planning, devising, or adapting methods to enhance process effectiveness at both captive and third-party manufacturing sites. The role requires a thorough examination of components, equipment, processes, operations, and finished device designs to identify opportunities for improvement. The successful candidate will be responsible for maintaining a cGMP compliant environment and adhering to FDA guidelines for Class II Medical Device manufacturing. This includes driving product and process improvements in alignment with Insulet's CAPA system, generating and coordinating validation/qualification protocols, and authoring Engineering Change Orders. Additionally, the role encompasses designing and coordinating the construction of manufacturing fixtures and supporting all project phases from concept through to implementation into manufacturing. The ideal candidate will possess a Bachelor of Science in an Engineering discipline or an equivalent combination of education and experience, along with 3-5 years of work experience in a manufacturing environment, preferably within the medical device industry. Strong communication skills, the ability to prioritize tasks, and a collaborative team spirit are essential for success in this role. Familiarity with manufacturing processes such as Injection Molding, Metal Stamping, PCB manufacture, and CAD software like ProEngineer or Solidworks is highly desirable. The position may require potential overnight travel of approximately 33% of the work week.

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/qualification protocols and coordinate their execution.
• Write validation/qualification final reports.
• Author and implement Engineering Change Orders.
• Design and coordinate the construction of manufacturing fixtures.
• Support all project phases from concept to implementation into manufacturing.
• Perform other duties as assigned.

Requirements

• Bachelor of Science in Engineering discipline or equivalent combination of education and experience.
• 3-5 years' work experience in a manufacturing environment is required.
• Experience in the medical device industry is preferred.
• 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.
• Manufacturing process knowledge (Injection Molding, Metal Stamping/forming, PCB manufacture, Manual and automated assembly, decorating, extrusion and ultrasonic welding) is a plus.
• Strong computer skills; MS Office / MS Project / Statgraphics.
• CAD (ProEngineer / Solidworks) experience is desirable.

Nice-to-haves

• Experience in the medical device industry is preferred.
• Manufacturing process knowledge (Injection Molding, Metal Stamping/forming, PCB manufacture, Manual and automated assembly, decorating, extrusion and ultrasonic welding) is a plus.
• Strong computer skills; MS Office / MS Project / Statgraphics.
• CAD (ProEngineer / Solidworks) experience is desirable.