About this role
Job Summary
Performs engineering work related to planning, devising, or adapting methods to improve process effectiveness at captive and third party manufacturing sites. Examines components, equipment, processes, operations, and finished device design to identify improvement opportunities.
Responsibilities
-
At all times 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, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports.
-
Author and implement Engineering Change Orders.
-
Design and coordinate the construction manufacturing fixtures.
-
Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
-
Perform other duties as assigned.
-
Education and Experience
-
Bachelors of Science in Engineering discipline and/or equivalent combination of education and experience.
-
Minimum Requirements
-
3-5 years’ work experience in a manufacturing environment is required.
-
Experience in the medical device industry is preferred.
-
Preferred Skills and Competencies
-
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 with the ability to 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) a plus.
-
Strong computer skills; MS Office / MS Project / Statgraphics.
-
CAD (ProEngineer / Solidworks) experience desirable.
-
Physical Requirements
-
Potential overnight travel of approximately 33% of the work week.
-
NOTE: This position requires on-site working (requires on-site office/plant/lab work). LI-Onsite
-
Additional Information
Compensation & Benefits:
- For U.S.-based positions only, the annual base salary range for this role is $76,400.00 - $114,575.00
- This position may also be eligible for incentive compensation.
- We offer a comprehensive benefits package, including:
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Application Details:
- This job posting will remain open until the position is filled.