Summary
With 17 years of expertise in medical device engineering, specialize in precision design of structural and plastic components, electrical schematics, and advanced wire harness systems. Leveraging CAD/CAM/CAE technologies, drive innovative, regulatory-compliant product development through robust design validation and process optimization.
Medical Devices Design Expertise & Key Capabilities
- Skilled in new product development and process validation, excel in integrating electrical and mechanical systems for functional safety and reliability.
- Proficient in advanced CAE simulation for early flaw detection, verification and validation (V&V), and test method validation (TMV), ensuring optimal device performance under physiological stresses including fatigue and thermal management.
Core Competencies and Contributions
- Experienced in risk management and requirement traceability, lead V&V planning and execution, develop rigorous test method validation protocols, and perform in-depth characterization testing to enhance device reliability.
- Utilizing virtual prototyping, digital twin technologies, and comprehensive lifecycle documentation, deliver high-quality, compliant medical devices through effective cross-functional collaboration.
Precision Manufacturing Solutions
- Delivered advanced device designs using CAD/CAM for precise modeling and manufacturability, leveraging virtual prototyping and digital twins to reduce development cycle time and cost.
Design & Analysis Tools
- CATIA V5, Siemens NX (3D CAD modeling, Drafting), Creo, SolidWorks, Solid Edge
- PDM, Teamcenter, Enovia LCA, Smart Team (PLM Systems)
- Finite Element Analysis (FEA) software for composites and structures
- MATLAB / Simulink (for systems modeling)
Devices
Medical devices, monitoring units, patient care systems, validation-driven hardware, and regulated product platforms.
Engineering
Structural and plastic design, schematics, wire harnesses, V&V, TMV, risk management, and digital twin enabled development.
Tools
CATIA V5, NX, Creo, SolidWorks, Solid Edge, Teamcenter, Enovia, Smart Team, FEA tools, MATLAB, and Simulink.
Need medical device engineering support?
Reach out for support in medical product design, structural and plastic engineering, validation planning, wire harness systems, and technical documentation.
