Senior Manufacturing Engineer

Cook GroupBloomington, IN
2d

About The Position

The Senior Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

Requirements

  • Bachelor’s Degree in Engineering
  • 5+ Manufacturing Engineering years experience, preferrably in medical device

Responsibilities

  • Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.
  • Work with Product Development Engineers to develop processes for new products.
  • Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.
  • Train all relevant personnel on new processes.
  • Document cost savings.
  • Write and execute validation protocols.
  • Assure projects follow design controls established by QSPs (Quality System Procedures).
  • Provide support to the calibration department in writing/performing calibration procedures.
  • Work with Quality Assurance and Product Development to verify/validate critical processes or products.
  • Work with management to establish project timeliness,and project justification.
  • Act as resource for operational departments for materials, equipment and process upgrades.
  • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
  • Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable.
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
  • Must strictly adhere to safety requirements.
  • Maintain regular and punctual attendance.
  • Must maintain company quality and quantity standards.
  • Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
  • Ability to remain calm and receptive in fast paced situations.
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