Expert Details
Medical Device Engineer
ID: 737241
Washington, USA
Product Definition | Design Verification & Validation | Usability Engineering
Design for Manufacturability | Process Development | Lean Six Sigma Manufacturing
Risk Management | Corrective & Preventative Action | Rapid Prototyping
Tooling & Equipment Development | Assembly & Test Documentation | Process Validation
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1990 | Degree: MS | Subject: Industrial/Manufacturing Engineering | Institution: Oregon State University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2017 to Present | Employer: Undisclosed | Title: Owner | Department: All |
Responsibilities:• Product Development – collaborate with clients to deliver new medical devices that meet business and regulatory needs by performing project planning, design inputs documentation, risk management, design verification, tool qualification, process validation, test method validation, device master record (DMR) creation, work cell design, and manufacturing training.• Design for Manufacturing (DFM) – part and assembly design using Solidworks CAD: injection molding, extrusion, machining, electrical and fiber optic cables, enclosures, catheters, vascular implant delivery systems. • Assembly Process Development – process optimization using design of experiments (DOE): low-pressuring injection molding, UV adhesive bonding, ultrasonic welding, wire harness assembly, electromechanical assembly, microcatheter assembly, heart valve catheter mounting. • Test Method Development: verification and in-process test methods for: tensile force, burst pressure, strain relief flexure, fluid ingress, electrical safety, hipot, optical power, leak rate (fluid/air), flow path occlusion, functional, electrical burn-in. • Assembly Tool Design – fixture design, fabrication (mill/lathe machinist), and qualification. • Clients include: EKOS Corp (BSC), Ondine Bio, Ventec Life Systems, ReValve Solutions. |
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