Khawja Mohinuddin Syed

About Khawja Mohinuddin Syed

As a professional in the medical device industry, I bring a wealth of experience across various engineering departments, particularly with Class-II and medical devices. My expertise lies in new product development (NPD) and legacy product modifications, where I excel in feasibility evaluations, product design verification, part qualifications, test method validation, and equipment validation. I am committed to enhancing manufacturing efficiencies, improving product quality, and reducing costs through innovative engineering approaches.I have a strong working knowledge of medical device standards such as ISO 13485, ISO 14971, and FDA 21 CFR 820, and I am proficient in validation protocols, FMEAs, MVP, DHF, SCAR, NCR, SOPs, and statistical techniques. My technical skills include SolidWorks (CSWA Certified), equipment qualification, design controls, process qualifications, process improvement, risk management, and production planning.I thrive in fast-paced environments, adeptly handling multiple responsibilities and adapting to changing needs. My strong oral and written communication skills enable me to effectively collaborate with cross-functional teams and stakeholders. I am well-equipped to drive continuous improvement and innovation in the medical device industry.

Experience

1. Senior Supplier Quality Engineer

   BD

   Sep 2024 — Present · Irvine, CA, US

   Advanced Patient Monitoring (APM) division for BD (formerly Edwards Lifesciences Critical Care)

Education

• Wright State University

  Master's degree, Mechanical Engineering

• Jawaharlal Nehru Technological University, Kakinada

  Bachelor's degree, Mechanical Engineering