Sapan B.

About Sapan B.

I’ve been where you are today.Working at the intersection of innovation and regulation in the medical device industry.Reviewing countless design inputs, building traceability matrices, aligning risk files, and ensuring every product meets global standards from concept to launch.And then facing the challenge of balancing safety, speed, and innovation while navigating ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, and IEC 62366-1 often all at once.Collaborating across R&D, Regulatory, and Clinical teams, ensuring every decision puts the patient first, without compromising compliance.All while managing shifting timelines, design changes, technical complexities, and the ever-present pressure to deliver safe, high-quality devices on time.As I said, I’ve been there.The solution is simple.The right systems thinking mindset, quality frameworks, and cross functional collaboration.That is what I offer.I’m Sapan Brahmbhatt a dedicated Design Quality Assurance Engineer with 6+ years of experience supporting Class II and medical devices, including pacemakers and digital health platforms (SaMD/SiMD). I specialize in driving quality by design, managing risk end-to-end, and ensuring global regulatory compliance throughout the product lifecycle.Whether it’s leading SDLC quality activities, supporting usability evaluations, or preparing for FDA and Notified Body audits I bring a proven track record of delivering compliant, patient-centric solutions that stand up to real world scrutiny.Let’s connect and explore how I can help bring quality, safety, and strategy together in the world of M••••••••@gmail.com

Experience

1. Lead Quality Engineer

   BD

   Oct 2025 — Present · Bengaluru, IN

Education

• Indus University Ahmedabad

  Bachelor's degree, Mechanical Engineering

  2012 — 2016

• Binghamton University

  Master's degree, Ms Industrial engineering