OVERVIEW:

The Process Engineer provides support to production, leads projects for product and process improvements, troubleshoots equipment and tooling, and assesses suitability of materials for current production requirements. Additionally, the role applies problem solving skills to enable innovation and/or continuous improvement to drive growth through efficient and effective process improvements. The individual must be able to work independently with limited supervision, delivering flexible solutions fit to the company’s fast-growing pace.

RESPONSIBILITIES:

  • Provide daily support, to troubleshoot and resolve production equipment and process issues.

  • Provide solutions to complex problems including, but not limited to, those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, PLM, and other applicable QMS / business processes.

  • Perform root cause analysis and implement process improvements to improve production yield.

  • Investigate and disposition nonconforming product, evaluate root cause and implement corrections to prevent recurrence.

  • Prepare and review manufacturing procedures, test protocols and reports, and other controlled documentation.

  • Provide technical expertise to cross functional team members.

  • Help design and develop tooling and fixtures to effectively manufacture new and existing products.

  • Help designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

  • May incorporate inspection and test requirements into the production plan.

  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

  • Ensures processes and procedures are in compliance with regulations.

Qualifications:

  • Bachelor’s degree in Engineering.

  • Reading, producing, and editing engineering drawings.

  • Class II Medical device and tooling design and troubleshooting.

  • Experience with risk-based failure mode analysis.

  • Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making process.

  • Knowledge of Lean and Six Sigma concepts and root cause tools highly desirable.

  • Experience in electromechanical medical device manufacturing environment.

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