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Sr Manufacturing Engineer - Woburn, United States - Katalyst HealthCares & Life Sciences
Description
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.
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.
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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