MEDICAL DEVICE MANUFACTURING ENGINEERING
20-year track record in production, process design and supervision of pre-FDA approved catheter designs, ASTE and column strength test manufacturing, fixture and tool design.
In-depth background as manufacturing machinist in R&D, fabrication, tool development, prototypes, parts design and communicating with groups that provide content for projects.
Manage planning, production, protocols, validation and documentation. Use experience as model shop manager involving delegation, communications, acquisition and record keeping.
Work with highly professional product development corporations in new products. Co-inventor
on 25 of 33 overall patents involving cardiac rhythms, coronary angioplasty and catheter-based cardiology treatments. Manage processes via CNC, mill, lathe, testing and validation.
Effective in global project teams, hardware, software systems, vendor procedures and training, machining production, technical support, budget management and problem resolution.
PROFESSIONAL EXPERIENCE
Boston Scientific Corporation (formerly Asmatx Inc.), Sunnyvale, CA 2008 – Present Model Shop Manager / Senior Manufacturing Technician / Fixture & Tool Designer
Asmatx, Inc. developed bronchial thermoplasty products. Following the acquisition of Asmatx
by Boston Scientific Corp., retained in same capacity as prototype and senior manufacturing manager. Boston Scientific develops, manufactures and markets medical devices.
• As developer and project lead, manage diverse projects strategically and decisively
• Plan, design, develop, test and improve medical devices
• Use CAD/CAM, Solid Works to generate designs, GeoPath to program and SurfCam to transfer
• Oversee manufacturing, quality assurance, labels and packaging
• Fabricate parts, tools using ceramics, stainless steel, metals, plastics and adhesive materials • Gather information from marketing and engineering and prepare level 3 R&D applications
• Perform automated machinery work with engineers using multiple machines
• Investigate part designs, test samples, manufacture components, fixtures and electrical parts • Analyze potential obstacles to patent filings, approvability, and create effective solutions
• Maintain machines, fixtures, and pneumatic, electrical and mechanical tools • Oversee budgets, team building and leadership working closely with engineering
• Achieve strong goal metrics, process monitoring and delivery of timeline targets
Hansen Medical Inc., Mountain View, CA 2005 – 2008
Model Shop Manager / Senior Manufacturing Technician / Fixture & Tool Designer
Hansen Medical develops robotic catheter systems for minimally invasive cardiac surgery. Followed FDA guidelines to process and validate equipment.
• Utilized management and design experience to define processes and design equipment • Set up, operated, managed model shop, and improved manufacturing processes • Designed, fabricated components, fixtures and tooling for the manufacture, test and
packaging of robotic steerable catheters and devices
• Tools included pneumatic, electrical, mechanical, software-driven and robotics
• Created assembly instructions for robotic catheter systems
Aptus Endosystems Inc., Santa Clara, CA 2004 – 2005
Associate Engineer
Designed and fabricated components, fixtures, tooling for manufacture, test, label, packaging
of medical devices including Endovascular AAA (abdominal aortic aneurysm) Repair System.
• Responsible for machine design and implementation
• Designed handle interlock system for device deployment
• Provided management of equipment and software
Bacchus Vascular, Santa Clara, CA 2003 – 2004
Associate Engineer
Joined this privately-held medical device company to develop and improve equipment that assists patients with deep-vein thrombosis and related vascular disease.
• Designed, fabricated components, fixtures and tooling for manufacture, test, labeling and
packaging of medical devices
• Advised internal operations and management with respect to validation requirements
• Created trimming fixture to measure and cut shrink tubing for miniature coil component, and
multiple unit alignment and gluing fixture to affix micro bearing to braided polyamide tubing
• Evaluated crimping process and redesigned fixture increasing tensile strength by 300%
Transvascular Inc., Menlo Park, CA 2000 – 2003
Associate Engineer
Joined medical s...
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