Sr. NPI & Validation Engineer (781063)

Ensure the timely and effective launch of new products in the manufacturing space thru early collaboration with systems and R&D teams. Provide validation expertise to manufacturing engineers to build departmental capability. Drive process improvements in support of Insulet’s primary manufacturing objectives: Best Quality, Best Service, and Best Cost. Support Global Manufacturing Engineering in all equipment and process validation activities: FAT, SAT, IQ, TMV, and PQ. Develop global processes for design transfer and manufacturing. Work with supply chain to ensure manufacturing plants can meet volume and forecast requirements. Autonomously interpret data to drive cost savings projects. Develop and deliver training to build the capability of plant engineering team as part of continuous improvement efforts. Ensure compliance with safety rules, quality policies, and employee guidelines. Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485.

Requires a Bachelor’s degree (or foreign equivalent) in Industrial Engineering or a directly related field plus six (6) years of medical device experience.

Must have four (4) years of experience in the following (experience may be gained concurrently):

Contributed to a team effort with structured problem solving tools, including at least one of the following: DMAIC, Six Sigma, or Black Belt

Validation of medical device manufacturing processes and equipment, including IQ, OQ, and PQ

Data analysis tools including DOE, process development, and Gage R&R

Measurement System Analysis of medical device manufacturing equipment

Developing manufacturing work instructions and procedures for new products

Setting up and maintaining product BOMs and Device Master Record (DMR) in a PLM including one of the following: Arena, Agile, or Windchill

Demonstrated capability working collaboratively with R&D, Quality, and Production to ensure design for Manufacturability (DFM) requirements are met and design transfer and production ramp activities are executed properly and on time

Will accept a Master’s degree plus four (4) years of medical device experience in lieu of a bachelor’s degree plus six (6) years of experience.

Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #781063 in the subject line.

Thank you.