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Sustaining Process Engineer

This company is dedicated to working collaboratively with their customers, taking their projects from rapid prototype into high colume production. Thier unparalleled technical expertise, proven experience and partnership with thier customers have allowed them to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Their primary capabilities include: nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. 

Education and Experience:

  • BS in Textile Science & Engineering, Mechanical Engineering, Chemical Engineering, Bio Medical Engineering or equivalent.

  • Minimum of 5 years of experience in Engineering with a focus on Lean Manufacturing and continuous improvement.

  • Certification in Lean and Statistical process required along with a proven track record of implementing lean, visual factory and CI programs. Green belt six sigma preferred.

  • Familiarity with Solid works and CAD systems for design preferred.

  • Knowledge of PLC programing preferred.

  • Knowledge of medical device regulations and/or qualifications within ISO13485 preferred.

  • Some direct experience with Knitting, Weaving, Braiding or Non-woven product development preferred.

Skills and Responsibility:

  • Drive assigned lean manufacturing and continuous improvement projects from initiation to successful completion. Manage improvement teams to maximize contribution of all employees.

  • Ability to work independently, with minimum supervision.

  • Develop process control to reduce variation.

  • Develop, track and maintain metrics for key production accounts.

  • Preform IQ/OQ/PQ and other activities related to changes and implantation of new equipment and process improvements.

  • Interact with customers, medical device engineers and quality/regulatory departments.

  • Interact with outside vendors, suppliers, and consultants. 

  • Support production product lifecycle changes.

  • Develop FMEA, Process Control Charts and other documentation and controls changes as required.

  • Perform IQ/OQ/PQ validations for new equipment and products following ISO13485. 

  • Support implementation of Lean Manufacturing and continuous improvement programs.

  • Use root cause and statistical tools to evaluate issues and increase yields and efficiencies in the company. 

 Please email a copy of your resume to

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