• Supported sustaining engineering for an FDA approved wearable remote patient monitor for COPD, leading post ramp qualifications, material DOE's and engineering validation for FDA letter to file

• Defined architecture for next generation device, performing risk analysis and drafting engineering requirements in cooperation with EE, algorithms and systems engineers, building form factor-equivalent and functional prototypes

• Developed a novel mechanical clothing attachment mechanism for wearable patient monitors, with successful retention through dozens of laundry cycles to satisfy patient compliance and safety requirements, with a 10 second installation time per device

• Led technical feasibility for two ODM/JDM manufacturers in SE Asia and Midwest USA on a next generation wearable device, leading engineering teams on enclosure design, while driving engineering validation and providing test equipment as needed

• Developed electrochemical assembly fixtures to withstand extremely corrosive liquids (H2SO4 and Nitric Acid) for sensor FPC assembly for a sweat-based blood glucose monitor

Developed early concepts and test fixtures for a weatherproof, lightweight battery enclosure

• Supported successful FDA 510K clearance as mechanical/manufacturing lead on a waterproof, remote patient monitor for COPD

• Planned, developed, executed and documented Design Validation and Verification (V&V), including building out and validating all test fixtures and equipment

• Designed and deployed functional test stations with operator lockout, supporting 100% inspection on 1000 units/wk, running through 200k units between service intervals remotely in non-climate controlled facilities

• Root caused manufacturing process issues and device failures to mitigate failure rate up to 50%

Designed automated test equipment for ALS sensors for internal validation and factory test

Designed and validated two axis gimbals for accelerometer tumble testing on fully assembled devices in internal validation and assembly lines approaching 60 UPH, with operator-friendly attachments