// Medical Device Engineering Executive

Sean
Cohen.

VP of Platforms, Manufacturing, and Advanced Tech R&D at Sibel Health. Twenty years taking Class II and III medical hardware from first prototype to global production under ISO 13485, FDA, and EU MDR.

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Sean Cohen, medical device engineering executive
Mountain View, California
20+Years in med device
13+Device platforms
10+Patents issued & pending
4Countries manufacturing
25–50%Product cost reductions
01

Career Arc

2012–2014Gainesville, FL

The inventor years

R&D Project Manager, Research Engineer · Xhale Inc.

Medical device systems engineering across conceptual design, prototyping, clinical trials, and regulatory. Ran clinical protocol development, data collection, and algorithm work while managing the engineering department's budget and schedules.

Invented six photoplethysmography sensing technologies for pulse oximetry, respiratory rate, and respiratory effort. That work seeded a patent portfolio that now spans cardiorespiratory monitoring and sensor fusion.

2015–2018Consulting & Senior Engineering

Full-stack device engineering

Senior Electrical & Software Engineer · Ximedica Dx / President · Fresol Engineering

Deep individual-contributor years across the whole device stack: precision optics, PID-controlled microfluidics, embedded firmware on ARM, C++/C# ground control software, and full PCB design in Altium. In parallel, ran a consultancy supporting investigational devices in clinical trials, including source documentation in the operating room.

Built V&V, production, and CAPA plans for 21 CFR 820 compliance and authored ISO 14971 risk management reports, the regulatory foundation for everything after.

2018–2023Bay Area, CA

Building hardware organizations

VP of Hardware Engineering · AliveCor, then Avive Solutions

Joined AliveCor as a senior electrical engineer and built the hardware organization from the ground up, leaving as VP of Hardware Engineering. Shipped mobile ECG and cardiac sensors with AI-driven arrhythmia diagnostics, owned hardware systems architecture, and led FCC, Bluetooth SIG, and IEC 60601 compliance. Then led hardware for Avive's always-connected Class III AED with real-time 911 responder integration.

Qualified multiple ISO 13485 contract manufacturers across Asia for 25%+ production savings, and cut flagship product manufacturing cost by 50% while improving durability and sterilization capability.

2023–PresentMountain View, CA

Platform scale

VP of Platforms, Manufacturing, Advanced Tech R&D · Sibel Health

Executive engineering leadership for FDA-cleared wireless wearable vital-sign platforms, including the ANNE One platform, spanning clinical care, clinical trials, remote patient monitoring, and advanced digital therapeutics. Owns the Device Master Record and design transfer across a manufacturing footprint covering the US, China, Malaysia, and India.

Owns the NPI roadmap for 13+ device platforms under ISO 13485, FDA, and EU MDR, aligning hardware, firmware, software, RA/QA, and clinical stakeholders across in-house and offshore teams.

02

Expertise

// Leadership

Executive Engineering Leadership

NPI roadmap ownership, cross-functional team building across EE, ME, FW, SW, RA/QA, budgeting, vendor negotiation, and executive communication.

// Quality & Regulatory

Medical Device & Quality

ISO 13485, 21 CFR 820, EU MDR, IEC 60601, ISO 14971. Design controls, risk management, DMR ownership, V&V strategy, CAPA and continuous improvement.

// Hardware

Hardware & Systems

Cardiac and vital-sign sensing, low-noise analog front ends, RF and wireless design, high-speed digital, PCB architecture, sensor fusion, system-level validation.

// Manufacturing

Manufacturing & Operations

Global contract manufacturers across the US, China, Southeast Asia, and India. Design transfer, line bring-up and qualification, process validation, cost reduction, geo-diversity strategy.

// Software

Software & Cloud

Embedded C/C++, C#, MATLAB, LabVIEW. Cloud and connected systems on AWS, Azure, and Google Cloud. Generative AI implementation lead.

// Prototyping

Rapid Prototyping & Infrastructure

3D printing, CNC, full electronics lab. Hands-on with self-hosted infrastructure: Proxmox, Docker, Kubernetes, ZFS storage, and n8n workflow automation.

03

Patents

10+issued and pending patents
  • Methods and systems for determining effectiveness of respiration in individuals
  • Unified display of cardiorespiratory parameters
  • Wireless telemetry sensor system

Portfolio spans cardiorespiratory monitoring, multi-sensor fusion, unified physiological parameter display, and medical packaging. Full list available on request.

04

Contact

The full record
lives on LinkedIn.

For roles, board conversations, or anything involving medical hardware at scale, LinkedIn is the fastest way to reach me.

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