Lewis C.

About Lewis C.

I lead the development of complex hardware products from early concept through manufacturing and market launch.Over the past 20+ years I’ve built and led multidisciplinary engineering teams developing medical devices, satellite communications systems and connected hardware platforms. My work sits at the intersection of electrical engineering, embedded systems, mechanical design, and product strategy, translating ambitious technical concepts into reliable, manufacturable products.I’m equally comfortable architecting product platforms, solving deep engineering problems and working directly with suppliers and contract manufacturers to bring high-fidelity hardware to market.Areas of focus include:• Hardware Product Architecture• Electrical, Embedded & Mechanical System Integration• New Product Development & Product Lifecycle Management• Manufacturing & Supply Chain Strategy• Cross-Functional Engineering Leadership• Reliability Engineering & Design for Manufacturability• Product Strategy & Customer-Centered DesignI have extensive experience navigating regulated product environments, including FDA and international regulatory pathways and building development processes that balance innovation, compliance and speed to market.Experience Highlights:∞ Development of FDA-regulated Class II and Class medical devices∞ Leadership of cross-functional engineering, regulatory, and manufacturing teams∞ Strategic planning for product development and manufacturing scale-up∞ Hardware architecture spanning PCB design, embedded firmware, and mechanical systems∞ Product lifecycle management from concept through production∞ Regulatory approvals including FDA (510k, De Novo), FCC, IC, and CE∞ Manufacturing experience across SMT electronics, injection molding, and final assemblyTools & TechnologiesMedical Device Development - Greenlight GuruElectrical Engineering - Altium Designer • Autodesk EagleMechanical Design - SolidWorks • Fusion 360Product Design & UX - Figma • BalsamiqCreative Tools - Adobe Illustrator • Affinity Designer • InkscapeProductivity - MS Office • MS Project • Atlassian SuiteIf you’d like to connect regarding hardware product development, engineering leadership, or new technology ventures, feel free to reach out.

Experience

1. Director of Engineering

   Alpha-Stim, by Electromedical Products International

   Sep 2022 — Present

Education

• University of Mary Washington

  Bachelor of Science, Environmental Science

Skills

• Program Management
• Supply Chain Management
• Sustainable Design
• Consumer Products
• Management
• Team Building
• New Business Development
• Electrical Engineering
• Creative Direction
• Business Development
• Design Research
• Product Design
• Manufacturing
• Project Management
• Strategic Planning
• Graphic Design
• Electro-Mechanical
• Getting the Job Done
• Product Development
• Industrial Design
• Mechanical Engineering
• Submittals
• Engineering
• Modeling
• Product Management