Senior systems engineer with extensive professional experience in designing and validating safety-critical embedded systems for medical device development. Specializes in FDA-regulated real-time control systems, usability engineering compliance (IEC 62366), and medical device lifecycle management including architecture, risk analysis, and regulatory approval. Has held director-level positions at several major medical device manufacturers and brings significant consulting experience serving leading medical device and healthcare companies. Expertise spans cardiovascular, ophthalmic, surgical robotics, drug delivery, and diagnostic platforms.

Formal Education

  • B.A. in Computer Science (summa cum laude), from a major research university
  • A.S. in Biomedical Technology (with honors), from a technical college
  • Graduate-level Computer Science coursework from a leading university
  • Engineering coursework and management seminars from a top-tier research institution
  • Graduate-level Computer Science coursework from a major research university

Career Highlights

  • Senior Consulting Systems Engineer serving leading medical device and healthcare companies
  • Director of Engineering, managing design and validation of diagnostic instrumentation under FDA regulations
  • Director of R&D, responsible for product development, regulatory submissions, and cross-functional team leadership
  • Director of Software Engineering, establishing IEC 62304-compliant development processes at a major medical device manufacturer
  • Manager of Hospital Electronics and Software, developing embedded systems for drug delivery applications
  • Directed cross-functional R&D teams of 35+ engineers across software, electronic, mechanical, and quality disciplines

Expert Qualifications

  • Retained as consulting and testifying expert for analysis of embedded software and control systems in patent infringement litigation
  • Deep expertise in FDA design controls, IEC 62304 medical software development, and ISO 13485 quality systems
  • FMECA and fault-tree analysis specialist for safety-critical systems risk assessment
  • Regulatory approval experience including FDA submissions, CE marking, and TÜV certification for Class III medical devices