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Sr Manufacturing Engineer
Job in
Danvers, Essex County, Massachusetts, 01923, USA
Listed on 2025-12-01
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.
- 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.
- Associate
- Contract
- Pharmaceutical Manufacturing
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