Lead Process Engineer
J-Pac, LLC - Somersworth, NH

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A dynamic, innovative and driven Lead Process Engineer is needed to join our Operations team. Candidates are required to have a degree in engineering with a minimum of five years process engineering experience within an ISO13485 Accredited medical Device/FDA approved manufacturing/packaging environment. Experience of Lean Manufacturing/Six Sigma techniques with excellent communication skills, sterile barrier packaging, skills in statistics, Gage R&R, FMEA’s, and ISO Quality Systems is essential.

The Lead Process Engineer will be responsible for directing the process engineer team and optimizing both old and new processes. This includes but not limited to process maintenance, clean room experience, process development and prototype manufacturing. Experience with thermoforming would be advantageous.

Some Key Responsibilities include working directly with customer’s engineering group on product development, perform equipment/process validations through IQ’s, OQ’s, and PQ’s, generation of all related documentation ( completion reports, work instructions, preventative maintenance schedules, FMEA’s, etc.), and release to manufacturing, and identify and lead cost saving initiatives introducing metrics.

This is a “hands on” role and the successful candidate requires being a self starter, excellent communicator, and has the ability to multi-task.

Monster - 2 years ago - save job