This position provides manufacturing engineering support to a manufacturing operation. This may include designing and implementing new manufacturing processes, designing manufacturing tooling, improving existing manufacturing processes, repairing and coordinating the repair of production machinery, and providing technical guidance to manufacturing personnel.
Investigate, justify and implement automation and new technology opportunities. Suggest product redesigns to reduce cost and cycle. Improve production processes, equipment and methods to reduce cost and cycle.
Provide assistance with CAD documentation, SOP’s, Test Instructions, PFMEA. See that necessary validations or verifications are performed according to Quality Systems Regulations.
Correct and resolve manufacturing issues to minimize production downtime.
Work on new product and process design teams as well as change coordination that may impact assembly operations and test procedures.
Lead and Assist with CAPA investigation, root cause analysis, deviations, etc. independently and within teams
Provide support, as necessary, to Quality team during audits
Assist with preventative maintenance activities, as required
Independently leads minor projects and change implementations.
Bachelor’s Degree in an engineering discipline or equivalent experience.
Bachelor's Degree in Engineering:
Mechanical, Electrical,Industrial, or
Minimum 3 years of experience in manufacturing support
3 -5 years in medical device manufacturing
SPC, Solidworks, MSProject, Office suite, Access a plus.