Sr Manufacturing Engineer

4 weeks ago

Woburn, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
  • Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on site Factory Acceptance Testing of equipment.
  • Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
  • Drive SAT (Site Acceptance Test) for Mfg. equipment necessary for internal/external Mfg. process in which client owns the product/process design.
  • Partner with R&D, Quality, Regulatory Affairs and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
  • Analyse product designs for best method of manufacture.
  • Work collaboratively in the design, development, and/or improvement of manufacturing processes and equipment.
  • Ensure that manufacturing has accurate and detailed information on specifications, with customer manufacturer under corresponding QMS (Quality Management System).
Requirements:
  • BSME with 5 years or MSME with 6 years mechanical design/engineering experience or equivalent combination of education and experience.
  • Experience on Process validation protocols and reports (IOQ/PQ) from manual to automated production lines.
  • Experience with FDA, ISO, and IEC standards a plus.
  • Experience with vascular products a plus.
  • Strong technical understanding of set up and maintenance of manufacturing processes.
  • Has supported medical device relocation efforts.
  • Strong problem-solving capabilities through tools and techniques to implement systematic solutions internal/external processes.

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