I am a mechanical engineer who is focused on medical device development.

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 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 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.

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.