Sumit M.

Experience

• Lead Engineer, Design NPD Biorad Medisys Pvt. Ltd. · Full-time Sep 2020 – Apr 2026 5 yrs 7 mos Pune, MH, India Conducted project benchmarking to assess competitor products and workflow efficiencies. Designed, verified, and validated GI stents to ensure optimal radial force and anti-migration performance. Created 3D/2D models using SolidWorks (per ASME Y14.100-2017) & performed Tolerance Stack-Up analyses on deployer assemblies.
  Collaborated cross-functionally to finalize DHF and DMR documentation in line with ISO 13485. Delivered key design control documentation, including DIOVV, DFMECA, risk analyses, and CQA. Participated in material selection focused on performance and biocompatibility. Supported Regulatory Affairs in 510(k) submissions and Marketing in IFU and labeling content.
• Executive- Design Engineer WiseArt Design Studio LLP · Full-time Jan 2020 – Aug 2020 7 mos Mumbai, MH, India Responsible for the reverse engineering, design calculations and generation of BOM of various projects assigned to me. Developed detailed Solid models, POCs and drawings of Modular Furniture considering DFM and DFA. Conducted a cross-functional project team in developing products from concept through to commercialization.
• Design & Development Engineer Biosense Technologies · Full-time Sep 2018 – Dec 2019 1 yrs 3 mos Mumbai, MH, India Designed point-of-care devices in accordance with project objectives with due consideration of project schedule, budget & risks. Performed engineering calculations & analysis of complex scope like custom designed parts and OEM selection such as Motor, Bearings, Lead-screw Rods, Lens, Color Sensors etc. and ensured that the product met the requirements for DFM & DFA. Developed design risk assessment (FMEA & Hazard Analysis), implementing controls or mitigation to reduce risk levels. Developed various Jigs & Fixtures to ease the assembly process at the production line. Delivered Design Control Documents (DCD) in accordance with ISO 13485 and ISO 14971 Risk Management.