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 years or MSME with 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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