Manufacturing Engineer

This position is responsible for leading as a central resource for Manufacturing and assists with day-to-day

production support and improvements. Responsible for managing all activities for sustaining engineering

philosophy, productivity and safety advantages, environment and implementation.

• Ensure QA compliance within regulatory standards such as FDA and ISO 13485, while achieving production Key Performance Indicators (KPIs).
• Lead concurrent engineering practices with Engineering to successfully transfer New Product Introductions (NPIs) within manufacturing.
• Perform/complete supplier qualifications, which includes, but not limited external process capabilities studies.
• Perform/complete process IQ/OQ/PQ qualifications, which may include PPQ validations.
• Review, create, revise, etc. manufacturing documentation (i.e. drawings, Work Instructions, Batch Records).
• Execute LEAN manufacturing techniques and principles, but not limited to:
• Must be a team player and understand motivating team members into a LEAN environment.
• Facilitate a “self-directed” manufacturing environment.
• Minor design/development of manufacturing fixtures and equipment.
• Identify manufacturing cost reductions and provide ROI justifications for change.