Expert Details

Expert in Medical Device Engineer

Expert ID: 737241 Washington, USA

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Collaborative and results-oriented medical device engineer with extensive new product development experience. Superior record of delivering results through teamwork, innovation, and focus. Versatile team member having experience in marketing, mechanical engineering, manufacturing, and project management. 47 patents in medical device industry.
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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