New product, process and manufacturing Electrical/ Chemical Engineer/ Project/ Systems Engineer with extensive experience (30 years) developing new technology and bringing it to volume manufacturing. Very successful in meeting “time to market” and “design for manufacturing” in several industry (Life Science, Medical Devices, EO and MEMS) Highly adaptable to new product commercialization environment where the role is hands on and have to quickly assume different responsibilities. Skilled in;- Quality Assurance in ISO 13485 (BSI certified Lead Auditor), 9001 and 21CFR part 820 environments. - Risk Management(ISO-14971), Compatibility (ISO-10993) and CleanRooms (ISO-14644)- Product Realization, Design Control, Change Management, Documentation Control, CAPA, Measurement, analysis and Improvement Validation & Verification (V&V) Protocols and IQ/OQ/PQ writing and implementation,- Requirements analysis, technology development, outsourcing, staff management, forecasting, functional test bed design and implementation, Bill Of Materials, validation, design cost reduction, mechanical and electrical trouble shooting, failure analysis, metrology, Capital Equipment design and procurement, and OEM vendor negotiations.- QMS and Work Instruction writing and training
Listed skills include Semiconductors, Thin Film Coating, Project Management, Photolithography, and 22 others.
