• 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 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.