Senior systems engineer with nearly 30 years of professional experience 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 pathways. This expert has held director-level roles at leading medical device manufacturers and brings two decades of consulting experience with Fortune 500 healthcare companies across cardiovascular, ophthalmic, surgical robotics, drug delivery, and diagnostic platforms.
Formal Education
- B.A. in Computer Science (summa cum laude) from San Diego State University
- A.S. in Biomedical Technology (with honors) from Grossmont College
- Graduate-level Computer Science coursework from San Diego State University
- Engineering coursework and management seminars from UCLA
- Graduate-level Computer Science coursework from California State University, Northridge
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
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Frequently Asked Questions
What types of cases can this expert support?
They handle patent infringement cases in medical devices, with particular strength in embedded control systems and software validation. Their background spans cardiovascular devices, surgical robotics, diagnostics, and drug delivery—the areas most likely to appear in litigation.
What is this expert's technical background?
B.A. in Computer Science (summa cum laude) and an A.S. in Biomedical Technology, plus graduate coursework from major universities. They've held director-level roles in software engineering, R&D, and product development at major medical device manufacturers, managing teams of 35+ across software, electronics, mechanical, and quality.
What technologies does this expert specialize in?
They specialize in real-time operating systems like QNX and VxWorks, and the regulatory frameworks medical devices must follow—IEC 62304 for software development, ISO 14971 for risk management, ISO 13485 for quality systems. Also experienced with FMECA and fault-tree analysis, FDA design controls, and CE marking for Class III devices.
- QNX and VxWorks real-time operating systems
- FDA design controls and premarket submissions
- IEC 62304 medical device software development
- ISO 14971 medical device risk management
- FMECA and fault-tree analysis
- Real-time embedded systems architecture
- Medical device software validation and verification
- ISO 13485 quality management systems
- U.S. District Courts
- Patent Trial and Appeal Board
- Arbitration Panels