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Sr Manufacturing Engineer

Katalyst Healthcares & Life Sciences - Hathorne, MA

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Job Description

Job Description: 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. As the Sr. Manufacturing Engineer, you will develop and implement process and product improvements typically for projects of complex scope and wide magnitude. Some other roles and responsibilities include: 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 and evaluate opportunities for improvement inherent in manufacturing processes and make specific recommendations for adoption. In partnership with Finance, perform detailed cost analyses of manufacturing changes, Cost reduction Projects. Production Support and Trouble Shooting: Provide engineering support to manufacturing operations. Address related issues arising on the production floor. Develop and Optimize Work Design, Manufacturing Layout and Product Flow: Using Lean Manufacturing principles, recommend and implement process layouts for efficient manufacturing. Keys: BS in Mechanical/Industrial Engineering or related. 4+ years of regulated experience. Continuous improvement and Cost Analysis. IQ OQ PQ validations. Problem-solving, Production and Troubleshooting support. Develop and Optimize work design, manufacturing layouts and product flow. Medical device experience (Cardiovascular experience is a plus).

Created: 2025-11-21

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