Ketan Karan Gaur

About Ketan Karan Gaur

I am a Senior Design Engineer with hands‑on experience developing life‑critical medical devices in highly regulated (FDA, ISO 13485, EU MDR) environments. My work spans the full product lifecycle — from early‑stage concept and risk assessment to design verification, validation, and post‑market issue resolution.My technical expertise centers on mechanical design of plastic polymer and precision components, with strong command over Siemens NX for 3D modeling, detailed drawings, DFM/DFA, and tolerance stack‑up analysis. I complement design capability with deep quality and regulatory ownership, having actively driven DFMEA, APQP, IQ/OQ/PQ, V&V, and CAPA investigations for field‑released products.At Philips, I worked on ventilators and respiratory drug‑delivery devices, leading MDR‑driven design changes under FDA 21 CFR 820. I have served as a site SME during FDA and internal audits, managing live investigations and compliance responses. I also led a full‑scope Cleaning Validation Gap remediation (AAMI ST 98:2022), covering risk management, V&V, usability inputs, and IFU updates — achieving zero gaps at release.Previously, I built a strong foundation in automotive and EV systems, designing injection‑molded and sheet‑metal components and executing GD & T‑driven tolerance studies for high‑volume manufacturing.I am currently expanding my skill set in Six Sigma, statistical problem solving, and Monte Carlo‑based risk analysis, with a focus on building robust, manufacturable, and compliant designs. I thrive in roles that demand technical rigor, ownership, and accountability — where engineering decisions directly impact patient safety and product reliability.

Experience

1. Sr Mechanical Engineer

   Philips

   Jul 2023 — Present · Pune, IN

Education

• Simpkins School

  Intermediate PCM, 12, Physics

  2015 — 2016

• Punjab Technical University, Jalandhar

  Bachelor of Technology, Mechanical Engineering

  2016 — 2020