About

I help medical device companies deliver safer, clearer, and more predictable development outcomes. My background spans software architecture, cross‑functional engineering leadership, regulated development, and quality systems — all grounded in hands‑on experience across Class I, II, and III devices.

My Background

I’m a medical device engineering and regulatory specialist with more than 30 years of experience building complex, safety‑critical systems. My work spans software, hardware, firmware, industrial design, clinical research tools, and verification automation. I’ve guided products from early concept through design controls, verification, validation, and regulatory submission.

I’ve worked with both startups and established manufacturers, giving me a practical understanding of how to scale processes, documentation, and communication as teams grow — without slowing innovation.

Areas of Expertise

• Software architecture & multi‑processor embedded systems
• Cross‑functional project leadership (software, hardware, firmware, clinical)
• IEC 62304 software lifecycle development
• ISO 14971 risk management & software FMEA
• Cybersecurity analysis & threat modeling
• QMS SOP development (ISO 13485, configuration management, coding standards)
• Verification & validation planning, automated test tools, traceability
• Design controls, documentation systems, and submission‑ready deliverables

Devices I’ve Worked On

• Critical care ventilators (Class III)
• Percutaneous heart pumps (Class III)
• Thrombectomy & atherectomy systems
• Surgical robotics & electromechanical instruments
• Tissue oximeters & optical diagnostic devices
• Telehealth platforms & home monitoring hubs
• Wearables & Bluetooth vital monitors
• Cryogenic aesthetic devices (non‑invasive fat removal)
• Clinical research & lab automation systems
• Home‑use devices (CPAP, medical scales, bladder diagnostics)

Representative Modalities & Technologies

• 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

How I Work

I bring structure, clarity, and forward momentum to engineering teams working under FDA, IEC, and ISO constraints. My approach blends technical depth with practical leadership — helping teams communicate better, document smarter, and deliver more predictably.

My Philosophy

Medical device development succeeds when engineering, quality, and regulatory work from the same playbook. I help teams build that alignment through clear architecture, strong processes, and risk‑based decision making.

Let’s Connect

If you need leadership, clarity, or technical depth in your development process, I’d be happy to talk.