Namit Kunalbhai Bhow

About Namit Kunalbhai Bhow

With over six years of experience in biomedical engineering and quality, I am currently contributing to Medtronic as a Design Quality Engineer II. I specialize in risk management, regulatory compliance, and quality control for medical devices, aligning my work with key standards like ISO 13485, FDA 21 CFR 820, and EU MDR. My passion lies in ensuring the reliability and safety of medical devices through collaborative cross-functional initiatives. Dedicated to driving innovation in the medtech industry, I strive to uphold Medtronic’s mission of alleviating pain, restoring health, and extending life. At Medtronic, I work closely with cross-functional teams to translate user needs into actionable design inputs and manufacturing requirements. My role focuses on leading ISO 14971-compliant risk management practices, authoring PRAs and FMEAs, and ensuring compliance with global regulatory standards for Class devices. I have also supported clinical and R&D teams to align MDR deliverables with industry guidelines, ensuring the development of high-quality medical devices that meet stringent regulatory expectations while addressing critical patient needs.

Experience

1. Design Quality Engineer Ii

   Medtronic

   Dec 2023 — Present

   Collaborated with cross-functional teams to translate user needs into design inputs and manufacturing requirements; defined reliability requirements and identified critical-to-quality (CTQ) components for medical devices.• Led ISO 14971 risk management by authoring PRA and FMEAs; identified and mitigated design/manufacturing hazards, performed complaint-based evaluations, monitored risk controls, and documented residual risk across NPD.• Directed EU MDR compliance for Class devices, ensuring adherence to MDD 93/42/EEC, FDA 21 CFR Part 820, ISO 13485/9001 and GMP requirements.• Assisted clinical and R&D teams in developing MDR deliverables in alignment with MEDDEV 2.7/1 Rev. 4, MDR Annex XIV requirements and General Safety and Performance Requirements (GSPR) mapping, ensuring full traceability to design inputs and outputs.• Supported EU MDR 2017/745 transition, managing MDR milestones and STED submissions to notified bodies; conducted gap assessments between MDD 93/42/EEC and MDR requirements, driving remediation plans for Class devices.• Supported manufacturing process validation and supplier qualification through SOQ and gap analysis; collaborated on product improvements and implemented statistical process control (SPC) to optimize manufacturing processes and equipment qualification protocols.• Authored process validation documentation, test method validations, and design verification protocols; performed TMV, Gage R&R, and process capability (CPK) studies.• Utilized comparative statistical tests (T-Test, F-Test) to analyze existing and newly developed designs; conducted root cause analysis using 5-Why techniques and Fishbone for process improvements.

Education

• San José State University

  Master's degree, Biomedical/Medical Engineering

  2021 — 2023

• Gujarat Technological University (GTU)

  Bachelor of Engineering - BE, Bioengineering and Biomedical Engineering