Senior Manufacturing Engineer

SUMMARY

We are seeking a Senior Manufacturing Engineer to be part of a revolutionizing medical device company that is changing the world of total knee replacement. You will be invovled in project scope of new and next gen products, improve effectiveness for existing products, line extensions, manufacturing technology transfers and exisiting product improvements.

We are unable to sponsor visas at this time.

JOBS DUTIES:

• Serve as the primary manufacturing SME between R&D and manufacturing operations.
• Provide technical direction to the vendor when designing the manufacturing process design from pilot concept to full-scale manufacturing, including requesting process changes to support the intended design.
• Compile and evaluate test data to determine appropriate limits and variables for process or material specifications.
• Develop new manufacturing practices as needed to ensure that manufacturing costs, technique and quality are kept current with external industrial practices.
• Work with engineering team(s) to develop final product solution for chosen architecture within time and cost constraints.
• Conceive, define, and plan projects involving selection of new manufacturing concepts, equipment automation technology, and risk-based approaches when developing new or improved processes.

QUALIFICATIONS:

• Bacheslors or Masters in Mechanical Engineering or equivalent field
• 5-8+ years of experience in process development, manufacturing with medical devices
• Strong history in application of Design for Manufacturability (DFM) and Design for Assembly (DFA) to perform tolerance stack-up within components and sub-assemblies
• Experienced with GD&T
• Experience with CNC machining (lathe or milling) and being able to process select and torubleshoot.
• Experience with medical manufacturing regulations such as 21CFR 820 and ISO 13485.
• Experience with IQ/OQ/ PQ
• Experience developing PFMEA, control plan, SOP, PPAP generation associated with product and manufacturing transfers.
• Experience with PLCM software (propel, confluence or smartsheet)
• Experience working with Jigs and fixture development
• Experience assessing fabrication processes based on component design including but not limited to metal casting, forging, injection molding and plastic machining.