Sujal P.
Data-Driven Medical Device Engineer
- Role
- Senior Manufacturing Engineer at Shockwave Medical
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Sujal P.
Highly skilled and experienced Design Quality Engineer/Sr. Manufacturing Engineer with years of experience in medical devices and pharmaceuticals industry. Proficient in Quality Engineering, project management, planning, Change order management system, CAPA, Risk Management (FMEA), DMAIC methodologies, cGMP FDA Quality system ISO 13485/21CFR Part 820, 21 CFR Part 11, and ISO14971.• Product Risk Management• CAPA/NCMR/NC/Exception• Process Validations• Lean Quality Tools (Pareto Charts, Fishbone Diagrams, Six Sigma, 5S, 8D Methodology)• Process Improvement• Failure Mode Effect Analysis (FMEA)• Statistical Process Controls (SPC)• Data Analysis ( Minitab, Excel )• New Product Introduction • Continuous Improvement tools (A3/DMAIC)
Experience
Senior Manufacturing Engineer
Aug 2024 — Present · San Francisco, CA, US
Education
Gujarat Technological University (GTU)
Bachelor of Engineering - BE, Mechanical Engineering
California Baptist University
Master of Science - MS, Mechanical Engineering
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