Experience

With more than 30 years of hands‑on experience across Class I, II, and III medical devices, I’ve supported engineering, software architecture, verification, risk management, and regulatory documentation for a wide range of technologies. My work spans critical care, surgical systems, diagnostics, wearables, telehealth, aesthetics, and clinical research tools.

Device Categories

• Critical Care: ventilators, percutaneous heart pumps, clinical data systems
• Surgical: robotic instruments, OCT catheters, atherectomy devices, thrombectomy systems, bone saws
• Diagnostics: tissue oximeters, embryo selection systems, lab automation tools, cryogenic thawing devices
• Wearables: Bluetooth vital monitors, smart rings, Parkinson’s therapy gloves
• Aesthetic / Energy‑Based: cryogenic fat‑removal systems, thermal control devices
• Telehealth & Home Monitoring: multi‑device hubs, cloud‑connected platforms
• Home‑Use Devices: CPAP, medical scales, bladder health diagnostics
• Clinical Research Tools: data acquisition systems, simulation tools, lab instrumentation

Modalities & Technologies

My experience spans a wide range of modalities, sensing technologies, and system architectures used in modern medical devices.

• Optical sensing (PPG, tissue oximetry, OCT)
• Cryogenics & closed‑loop temperature control
• Pneumatic control systems
• RF & optical biosensing
• Multi‑processor embedded systems
• Bluetooth/BLE wearable systems
• National Instruments DAQ systems
• Cloud‑connected telehealth platforms
• Clinical lab instrumentation
• Desktop and application‑level software for clinical research

Representative Activities

Across these devices, I’ve provided engineering leadership, architecture, verification, and regulatory‑aligned documentation, including:

• Software architecture, SRS, SDD, interface definition
• System and software verification planning
• Automated verification tools and simulators
• Hardware‑in‑the‑loop test systems
• Risk management (SFMEA, DFMEA, hazard analysis)
• Cybersecurity analysis & threat modeling
• Design controls, trace matrices, and documentation workflows
• QMS SOP development (ISO 13485, configuration mgmt, coding standards)
• Cross‑functional project leadership across SW, HW, FW, and clinical
• Clinical research tools, data acquisition systems, and lab automation

Representative Device Experience

Below is a selection of device types I’ve supported throughout my career:

• Critical care ventilators (Class III)
• Percutaneous heart pumps (Class III)
• Hydrodynamic thrombectomy systems
• Atherectomy devices
• Surgical robotic instruments
• OCT‑guided re‑entry catheters
• Tissue oximeters and optical diagnostics
• Telehealth monitoring hubs
• Wearable vital monitors and smart rings
• Cryogenic fat‑removal systems
• Clinical research data acquisition systems
• Lab diagnostic and thawing devices
• Home‑use CPAP and respiratory devices
• Medical scales and bladder diagnostics
• Parkinson’s therapy gloves and synchronized stimulation systems

How This Experience Helps You

My broad device experience allows me to quickly understand your system architecture, identify risks, strengthen documentation, and guide engineering teams toward compliant, predictable development. Whether you’re building a new device or preparing for submission, I bring the technical depth and regulatory alignment needed to move forward with confidence.

Let’s Talk

If you need engineering leadership, architecture support, or regulatory‑aligned development expertise, I’d be happy to help.