I am a mechanical engineer based in Naples, FL who is focused on medical device development.

What can I help you with?

 

Developing Devices

  • Brainstorming and designing new device concepts.

  • Brainstorming and designing solutions to overcome challenges.

  • Designing for low/high-volume manufacturability and assembly using processes such as machining, plastic/metal/ceramic injection molding, extrusion, stamping, fine blanking, casting, powder metallurgy, cold forging, additive manufacturing, heat setting, coating, welding, adhesive bonding, mechanical joining, and flexible clip-together assembly.

  • Designing and optimizing mechanisms for user controls such as levers and triggers.

  • Designing mechanisms for safety lockouts, kickbacks, and releases.

  • Developing industrial design style, look, and feel.

  • Selecting materials for manufacturability, assembly, robust function, biocompatibility, sterilization, and reprocessing.

  • Designing devices to meet applicable IEC standards for electromechanical and electrosurgical devices.

  • Producing engineering drawings.

  • Building proof-of-concept prototypes and conducting builds to support testing and user feedback activities.

Developing Fixtures

  • Developing fixtures for manufacturing and assembly. Examples include fixtures for high-voltage electrical testing, precision measurement via digital optical micrometer, end effector force measurement, laser welding, cutting to length, heat setting plastic catheters, etc.

  • Developing fixtures for engineering, pre-verification, and verification testing. Examples include fixtures for end effector torque measurement, non-destructive tensile testing, etc.

  • Developing fixtures for prototyping. Examples include fixtures for heat setting expandable nitinol components, bending and forming metal, etc.

  • Evaluating fixtures to ensure requirements for form, fit, function, and safety are met.

  • Producing engineering drawings and documentation for fixtures.

Troubleshooting, Analyzing, and Testing

  • Troubleshooting and resolving device issues and failure modes encountered in manufacturing, testing, and clinical use.

  • Analyzing devices for legal litigation and patent protection.

  • Analyzing, optimizing, and measuring forces and movement within mechanisms for user controls such as levers and triggers.

  • Analyzing tolerance stacks and performing finite element analysis (FEA) to ensure proper form, fit, function, and robustness.

  • Performing aggressive misuse testing to evaluate device robustness and reveal potential failure modes.

  • Analyzing and/or measuring resistance, impedance, dielectric strength, capacitance, capacitive coupling, inductance, leakage current, and power curves of electromechanical and electrosurgical devices.

  • Performing engineering, pre-verification, and verification testing. This includes testing per applicable IEC standards for electromechanical and electrosurgical devices.

 

Coordinating and Documenting

  • Leading technical teams.

  • Leading and participating in design reviews.

  • Managing and contributing to input, output, verification, and validation (IOVV) matrix.

  • Developing requirements and specifications.

  • Managing and/or contributing to various risk management processes such as risk analysis, design/process/application failure mode effects analysis (DFMEA, PFMEA, AFMEA).

  • Identifying and addressing requirements for testing, processes, labeling, marking, instructions for use, and documentation per applicable IEC standards for electromechanical and electrosurgical devices.

  • Developing manufacturing process instructions (MPI) and rework instructions.

  • Managing and/or contributing to issues lists.

  • Writing and submitting patent disclosures.

  • Writing protocols and reports.

  • Managing and/or contributing to bill of materials (BOM).

  • Participating in user feedback activities such as pre-clinical labs and product introductions.

  • Coordinating with suppliers of components, subassemblies, and equipment.

  • Managing subcontractors and other independent contractors when applicable.

  • Coordinating with external testing labs such as Intertek.

  • Coordinating with assembly operators and technicians to build and test devices.

Rendering, Animating, Photographing, and Filmmaking

  • Producing renderings and animations of devices, device/user interaction, device/patient interaction, manufacturing and assembly processes, medical procedures, and medical anatomy for the purposes of mockups, visualizations, learning, teaching, information sharing, and marketing.

  • Producing photos and videos of devices, device/user interaction, device/patient interaction, pre-clinical testing, user feedback activities, manufacturing and assembly processes, and bench testing for the purposes of capturing qualitative testing data, learning, teaching, information sharing, legal analysis, documentation, and marketing.