Responsibilities:

•    Manage projects which support the OEM Strategic Initiatives
•    Manage transfer activities for specific production cells
•    Establishes and defines technical scope and objectives for strategic initiative projects
•    Develops project plans, specifies the project goals, strategy and schedules, identifies areas of risk, contingency plans, cost/budget estimates and allocation of resources or capital
•    Identifies and schedules project deliverables, milestones, and required tasks
•    Quickly and clearly communicates issues, risks, and risk mitigation plans to management
•    Prepares project status reports to keep management, customers, and contingency plans that may be required
•    Provide technical guidance to engineers and technicians in multiple OEM facilities in support of the OEM strategy
•    Liaison between Product Development and Manufacturing during product transfers to ensure successful transition and design for manufacturability
•    Support Process FMEAs and production transfer documentation
•    Coordinate the design, procurement, build and troubleshooting of tooling, machinery and test equipment
•    Reduce cycle times and identify process improvements utilizing lean manufacturing principles and quality first mentality
•    Independently write and execute validations and/or assist technicians and other engineers in executing validation protocols (IQ/OQ/PQ)
•    For Senior level only – Mentor and coach less experienced engineers and technicians
•    Drive a safety driven culture
•    Other duties as assigned

Requirements:

•    Bachelor’s degree in Engineering required with a focus in Plastics, Manufacturing, Biomedical or Mechanical Engineering preferred.
•    2 – 5 years’ experience in a medical device manufacturing or heavily regulated industry.
•    Previous product transfer experience a plus