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. * Extensive experience in the design and development of automated processes for new and existing products leading Process Validations (PV), Risk Evaluations and to ensure all process remain in a Validated state using Design Failure Mode & Effect Analysis (DFMFA). * Served as a Leader for Manufacturing Engineering and tech team that handles implementations and validations of new medical device products, supporting existing equipment and development of new automation systems in the production department using PFMEA and DFMEA. * 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). * Detailed knowledge and exposure to Validating new outside vendors, acting as an engineering representative for MRB's, developing/ implementing new processes, troubleshooting outside processes, reviewing products for ease of manufacturing, and evaluating material and design failure with DFMEA, PFMEA and lab testing to failure of material and design. * Supported the Production Design and release of products including a Mini Laparoscope with discrete lens on the image fiber, deflecting 8.5F Choledochoscope and cystic duct access kit, implantable devices, Dental devices, Vascular, Urology and Laparoscopy devices, and other healthcare and medical products * Skilled in Optical, Opto-Mechanical, Electro-mechanical systems and devices, Process Development, Assembly Engineering, and Engineering Changes / ECN's. Able to create, build, test, evaluate, verify, validate, release and drive processes for manufacturing including all necessary documentation within highly regulated environments * Experienced in the manufacturing and design of mechanical and optical devices/ systems, driving enhancements, as well as, quoting, writing, implementing production schedules, and performing follow-ups on all materials and vendors.

Highlights:

• Manufacturing
• Documentation
• Purchasing
• Test
• Critical Care - Vascular
• ISO
• ISO 9000
• LAPAROSCOPY
• Product Development
• Urology