Principal at Satkarma Medical Devices (2002-01 – Present)
Medical Device Research and Development Consultant. Consultant with extensive expertise in the entire spectrum of device development, from ideation through clinical trials.
- Lead cross-functional engineering projects spanning design, prototyping, verification testing, and manufacturing transfer.
- 2023–2026: Temporarily reduce consulting activity while serving as primary caregiver for an elderly parent with Alzheimer's.
Project Manager at Abbott Vascular (2022-07 – 2023-01)
- Conduct a feasibility study for a novel small bore vessel closure device that utilizes bioresorbable implants.
- Collaborate with cross-functional teams to document user needs and intended use.
- Create a detailed project timeline for the design, development, verification and validation testing, IDE and PMA submission, leading up to the device's projected US release in early 2027.
Research and Development Engineer at Hayes Manufacturing (Prototek) (2010-01 – 2022-12)
- Collaborate with the company founder, Matt Hayes, to create manufacturing solutions for life science and medical device projects.
- Partner with Intuitive Surgical to redesign their package leak testing tank used in product validation.
Research and Development Engineer at Genentech (2016-05 – 2017-11)
- Collaborate with Dr. Maj Hedehus to design and fabricate an adjustable rodent bed with integrated anesthesia chamber for MRI studies.
Research and Development Engineer at Cirtec Medical (2002-01 – 2014-12)
A medical device development and contract manufacturing incubator.
- Mynosys (Zepto) – Automated Capsulotomy Device: Collaborate with Dr. David Chang in the development of a device that reduces surgical risk during cataract procedures. Contribute to the creation of a functional prototype and support successful in-vivo testing using bovine eyes.
- EBR System – Wireless Pacemaker: Oversee the transition of a leadless pacemaker prototype to a cleanroom production facility in Massachusetts. Develop and document manufacturing process instructions for laser welding the assembly of the implantable battery case and transmitter.
- St. Jude Medical – Large Bore Vascular Closure Device: Design and develop a gel block and circulatory system for design verification of a large bore vascular closure device.
- CardioRobotics – Adjustable Surgical Table Arm: Design and prototype an adjustable arm for mounting the company's Robotic MedProbe onto a surgical bed rail for precise positioning.
- Ethicon Endo-Surgery – NOTES (Natural Orifice Translumenal Endoscopic Surgery) Toolbox: Design, develop, verify, and package a minimally invasive, flexible electrosurgical hook knife and control handle for clinical trials. Contribute to the design, development, verification, and packaging of a flexible ligation clip delivery device and handle intended for clinical trials. Play a key role in designing, developing, verifying, and packaging a multi-clip reloader compatible with the ligation clip delivery device for clinical trials.
- FoxHollow (ev3) – Arterial Plaque Excision Console: Design and build a console integrating a PC, isolation transformer, video capture system, and Optical Coherence Tomography (OCT) imager. Complete Electromagnetic Compatibility (EMC) testing at Bay Area Compliance Labs. Set up and support the console system for porcine validation testing at Stanford Catheter Lab under Dr. John Simpson.
- Pulmonx – Bronchial Aspirator: Lead the electro-mechanical design of a LabView-controlled lung aspiration device. Oversee prototyping, testing, verification, and validation activities. Manufacture six systems in accordance with FDA GMP guidelines for European clinical trials under the Cirtec Medical quality management system. Maintain the Design History Folder (DHF) and the Design Master Record (DMR) and transfer documentation to Pulmonx.
- Aciont – Drug Eluting Contact Lens: Design and prototype a drug-delivery contact lens in collaboration with Aciont's clinical team. Coordinate with physicians for lens fitting in preparation for in-vivo animal trials conducted at the University of Utah.
- Catharos Medical Systems – Angio Contrast Dye Removal System: Design and test a catheter-based opto-electromechanical control system for the purpose of removing radiocontrast dye used in cardiac imaging. Collaborate with inventor Dr. Ali Hassan in conducting in-vitro testing.
- GrantAdler – Vascular Access Port: Develop a one-piece design of an implantable titanium vascular access port.
Senior Mechanical Engineer at Clarity Medical Systems (2004-02 – 2004-10)
- Design and develop an injection-molded housing for a digital retinal imaging prototype.
- Build a functional device for trade shows.
- Collaborate with an ophthalmologist and an industrial designer to optimize ergonomics and enhance patient comfort during examinations.
Senior Mechanical Engineer at BC Tech (1999-01 – 2001-12)
A medical product development and contract manufacturing firm.
- Radiant Medical – SetPoint Temperature Regulator: Collaborate with electrical and software teams to design and prototype an endovascular temperature therapy console using SolidWorks. Manufacture five clinical units under internal QMS to comply with ISO 13485 and FDA 21 CFR Part 820. Document the design and manufacturing activities in the Design History File and Device Master Record.
- Vivometrics – LifeShirt Continuous Ambulatory Monitoring System: Design electro-mechanical packaging incorporating a rechargeable lithium-ion battery to enable real-time tracking and recording of essential physiological parameters such as heart rate, respiration, blood pressure, blood oxygen levels, and physical movement. Collaborate with industrial, electrical, and firmware engineers to deliver thirty prototypes within a four-month development schedule, enabling the client to secure continued investor funding. Manage the establishment of an FDA-compliant production facility to support clinical builds of the LifeShirt garment and recorder.
Senior Mechanical Engineer at Microsoft (1996-01 – 1998-12)
- Design, develop, and test the scroll wheel mechanism for the production version of the Microsoft Intellimouse.
- Reduce pilot production costs by modifying plastic components and evaluating, testing, and selecting optimized electromechanical components.
- Design and develop manufacturing test fixtures for offshore production.
