Prashant Mani Upadhyay
System Design Engineer @ ThermoFisher Scientific | Medical Devices | R&D Project Engineer | NPD | Sustenance | VAVE | RCA | FMEA | FEA | DFM/DFA/DFX | FDA | ISO 14971 / 13485 | 21 CFR Part 820 / Part 11 | IQ/OQ/PQ | V&V
- Role
- Thermal Engineer at Thermo Fisher Scientific
- Location
- Varanasi, UP, IN
- LinkedIn followers
- 500 followers
About Prashant Mani Upadhyay
Mechanical & Thermal Systems R&D Engineer with 4.5+ years of experience delivering end-to-end product development for regulated life science and laboratory equipment. Proven expertise in mechanical, thermal, and refrigeration system design; DFMEA/PFMEA driven risk mitigation; verification and validation (IQ/OQ/PQ); and global manufacturing readiness. Strong track record of launching multi regional products, driving VAVE initiatives, improving energy efficiency and reliability, and collaborating with cross functional teams (Product, Quality, Regulatory, Manufacturing) in ISO 13485 and FDA regulated environments.Core Engineering Domain Expertise: Mechanical, Thermal & Refrigeration System Design New Product Development, Sustenance & VAVE Thermal / Airflow / Pressure-Drop Analysis Design for Manufacturing & Assembly (DFM/DFA)Risk, Quality & Compliance: Risk & Reliability Engineering (DFMEA, PFMEA, RCA, 8D) Product Validation, Qualification (IQ/OQ/PQ) & Regulatory ComplianceEngineering Tools: CAD: SolidWorks, Creo, Pro/E Analysis: ANSYS (FEA), MATLAB, Mathcad, Python PLM/Enterprise: SAP, PLM, ECN/ECO, BOM ManagementStandards & Regulations: ISO 13485, ISO 14971, FDA, CE, GMP 21 CFR Part 11 & 820 ANSI Y14.5 (GD & T), ASME, IEC 60601 / 61010
Experience
Thermal Engineer
May 2022 — Present · Hyderabad, IN
Education
Sardar Vallabhbhai National Institute of Technology, Surat
MTech, Turbo Machines (Mechanical Engineering)
2019 — 2021
Noida Institute of Engineering & Technology
BTech, Mechanical Engineering
2013 — 2017
Skills
- Autocad
- Powerpoint
- Mechanical Engineering
- Engineering
- Manufacturing
- Microsoft Office
- Ptc Creo
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