Manufacturing Engineer (On-site)

Job description

Position Overview: 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: -...