Here is the Process Engineering role that I was discussing. We need someone that is a very strong communicator with at least 5 years experience. Also this really is more of a Validation Engineer. They need to have IQ/OQ/PQ and MSA, and TMV experience.

Responsibilities:

Select inspection strategies for critical quality attributes on components

Complete Test Method Validation studies and generate subsequent Inspection documentation

Troubleshoot failures in TMV studies and provide appropriate solutions

Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the new product development procedures.

May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.

Lead and/or participate in process review meetings.

Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.

Review and approval of validation documentation.

Preferred Skills:

Regulated manufacturing industry. (Medical device)

Demonstrated ability to deliver project tasks on time with a focus on quality required.

Experience troubleshooting and solving engineering related problems

Experience with a wide variety of inspection tools and their qualification

Experience executing Measurement System Analysis (MSA)

Experience reading and interpreting engineering drawings and understanding geometrical dimensioning and tolerancing and validation

Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques

Good knowledge of manufacturing processes, materials, product and process design