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Sr Manufacturing Engineer

Job in Danvers, Essex County, Massachusetts, 01923, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-12-01
Job specializations:
  • Engineering
    Manufacturing Engineer, Process Engineer, Quality Engineering, Lean Manufacturing / Six Sigma
  • Manufacturing / Production
    Manufacturing Engineer, Quality Engineering, Lean Manufacturing / Six Sigma
Job Description & How to Apply Below

Overview

Our Advanced Manufacturing Engineering group located in Danvers, Massachusetts is part of our Interventional Vascular & Structural Heart (IV&SH) group. We are currently seeking a Senior Manufacturing Engineer to lead and support projects within our Advanced Manufacturing Engineering group.

Responsibilities
  • Develop and implement process and product improvements typically for projects of complex scope and wide magnitude.
  • Equipment and fixturing: determine specific requirements of manufacturing operation to specify equipment, fixturing, and process parameters.
  • Qualification and validation: develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
  • Continuous improvement and cost analysis: improve manufacturing methods, optimize product performance and reduce manufacturing costs in a systematic fashion; deploy Lean 6 Sigma methodology to identify opportunities for improvement and make recommendations.
  • In partnership with Finance, perform detailed cost analyses of manufacturing changes and cost reduction projects.
  • Production support and troubleshooting: provide engineering support to manufacturing operations and address issues on the production floor.
  • Develop and optimize work design, manufacturing layout and product flow using Lean manufacturing principles.
Qualifications
  • BS in Mechanical/Industrial Engineering or related field.
  • 4+ years of regulated experience.
  • Continuous improvement and cost analysis experience.
  • IQ/OQ/PQ validations.
  • Problem-solving, production and troubleshooting support.
  • Experience developing and optimizing work design, manufacturing layouts and product flow.
  • Medical device experience; cardiovascular experience is a plus.
Seniority level
  • Associate
Employment type
  • Contract
Industries
  • Pharmaceutical Manufacturing
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