Robert Fishburn Email & Phone Number

Summary:• Results-driven Manufacturing & Product Engineering Professional with a strong background in process development and validation, technology, product transfers, fixture design, development, and validation within highly regulated medical device environments including optical, opto-mechanical, and electro-mechanical systems and devices.• 10+ Years’ Experience in writing validation/verification protocols and reports, as well as, documenting and developing manufacturing processes and equipment. Experienced in supporting medical device manufacturing, engineering, and global manufacturing teams, designing and overseeing acquisition of new equipment for automation in production, and setting budgets for production development for new products and process improvements.• Direct experience in the design and development of new Optical medical device products from design, validation to production release; performing design improvements to existing products including review of protocols and test reports before implementations, defining additional testing to add CE (ISO 9000) mark to products and design input on design reviews. • Strong knowledge and experience with ISO 13485 and transfer of Medical Devices from R&D to Manufacturing. Hands on process development in Fixture design, development, assembly, and Fixture IQ, OQ, PQ, and PV• Experienced in Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), process optimization, as well as, supporting ISO 13485 compliance and transfer of Medical Devices from R&D to Manufacturing.• Experience implementing and managing Lean manufacturing principles, as well as, utilizing strong knowledge of ISO, GMP, GD&T, DFMEA, PFMEA and MDD requirements, and applying a strong background with fit and function evaluation, tolerance studies and design studies using Geometric dimensioning and tolerancing (GD&T)

Listed skills include Manufacturing, Medical Devices, Product Development, Manufacturing Engineering, and 28 others.

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  California State University, Long Beach

  Mechanical Engineering