Engineering‑Driven Medical Device Leadership for Software, Verification & 62304

Helping teams deliver safer, clearer, and more predictable medical device software across Class I–III systems.

I help medical device companies design, build, and deliver complex regulated products. With deep experience in software architecture, verification, risk management, and Class II/III development, I bring clarity, structure, and forward momentum to engineering teams working under FDA, ISO, and IEC constraints.

What I Do

I partner with medical device teams to strengthen engineering execution, improve software and system architecture, align development with regulatory expectations, and reduce risk across the entire product lifecycle.

I’ve led cross‑functional teams across software, hardware, firmware, industrial design, and clinical research — from early concept through verification, validation, and submission.

Experience Across Regulated Devices

Class I, II & III devices, including:

• Critical care ventilators
• Percutaneous heart pumps
• Thrombectomy and atherectomy systems
• Surgical robotics and electromechanical instruments
• Tissue oximeters and optical diagnostic devices
• Telehealth platforms and home monitoring hubs
• Wearables and Bluetooth vital monitors
• Cryogenic aesthetic devices (non‑invasive fat removal)
• Clinical research and 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
• Multi‑processor embedded systems
• RF and optical biosensing
• National Instruments DAQ systems
• Bluetooth/BLE wearable systems
• Cloud‑connected telehealth platforms
• Clinical lab instrumentation

How I Help

Software Architecture & Development Leadership
Embedded systems, application‑level software, multi‑processor architectures, verification tools, and automated test systems.

Cross‑Functional Project Management
Coordinating software, hardware, firmware, clinical, and regulatory teams to deliver integrated, compliant systems.

Regulatory‑Aligned Engineering
IEC 62304, ISO 14971, cybersecurity, design controls, traceability, and submission‑ready documentation.

QMS & SOP Development
ISO 13485 documentation, software lifecycle SOPs, configuration management, coding standards, and process templates.

Risk Management
Software FMEA, system hazard analysis, cybersecurity threat modeling, and risk‑based decision frameworks.

Verification & Validation
System V&V planning, protocol development, automated verification tools, and trace matrix creation.

Process Improvement
Helping teams communicate better, document smarter, and deliver more predictably under regulatory constraints.

Services

I support medical device teams across software, architecture, compliance, and cross‑functional development.

Project Leadership
Cross‑functional leadership for software, hardware, firmware, and industrial design teams.

Software Architecture
Guidance for embedded and application‑level medical device software, including verification tools and simulators.

Compliance & Risk
IEC 62304, ISO 14971, cybersecurity, QMS SOPs, and audit‑ready documentation.

Process Improvement
Helping teams communicate better, document smarter, and deliver more predictably.

Let’s Talk

If you need experienced leadership to guide your medical device development, improve software execution, or strengthen compliance, I can help.