Head of Manufacturing at Synectic responsible for pushing forward medical device projects from the design and development phases into production phases. Specializing in low volume, fully traceable early production of lots for use in Design Verification Testing and clinical trials.

At Butterfly Network, a startup making a $2,000 fully-body ultrasound probe, was responsible for the design, testing, manufacturing and quality of the mechanical components of the device. Designed and developed machined aluminum housings, button assembly and transducer head assembly to integrate device’s electronics into a mechanical assembly that meets IE 60601, thermal, disinfection, IPX7 and drop requirements. Worked with overseas factories to address DFM/DFA issues, to apply statistical process control for production validation and to setup an on-site digital optical measuring system to ensure outgoing quality. Using Solidworks PDM, created 3D models and assemblies, performed 3D analysis and FEA, and created 2D drawings applying Y14.5M-2009 and GD&T dimensioning to ensure parts met design input requirements.

At Facet Medical Technologies, a contract manufacturer of high-volume single-use disposable medical devices for diabetes, was R&D engineer responsible for the design, development and execution of new products. Project manager and engineer in charge of developing and launching CareFine pen needles for US market. Designed unique 5-bezel needle tip solution to compete with market leader. Performed design verification to meet ISO 11608 requirements. Worked with regulatory and design validation groups on 510k submission and clinical evaluation. Completed development and execution of a syringe system for an insulin delivery patch. Worked with customer to translate requirements into design input matrix and design output specifications. Developed test methods to meet ISO 8537 and ISO 594 standard. Managed 3rd party lab testing, including accelerated shelf life aging. Applied risk management, per ISO 14971, including DFMEA. Managed process qualifications of new molding and assembly equipment. Completed DHF for project. Other projects include: led design team to develop a new low-cost single use “safety” lancet; ensured manufacturability of etched, stamped and co-molded insert needle design; supported the qualification of a multi-million dollar lancet production facility, and revised Facet’s stage gate process and design control to better align with ISO 13485 and 21 CFR 820.30In charge of Facet’s co-op (internship) program. Supervised and mentored 2-3 Georgia Tech engineering students per semester. Prepared students for a career in engineering, introducing them to medical device development, manufacturing and marketing.

At Case-Mate, a phone case and accessories company, managed the launch of 20+ new phone case lines. Collaborate with industrial designers and marketing to develop manufacturable designs. Made 4 trips to Asia to manage tooling kick-off, and expand factory capabilities. Setup testing process to verify first article samples. Resolved process issues with Quality engineers.Designed an iPad case with integrated “soft” keyboard. Collaborated with outside design firm and rapid prototype vendors to develop a functional product. Worked with factories in Asia to develop new manufacturing processes.Trained & mentored 6 new engineers (including 3 in China) on Case-Mate’s project management system and first article testing process. Oversaw the outsourcing of line extension projects to Case-Mate’s China office.Designed a patent-pending screen protector that can be perfectly applied in under 10 seconds. Worked on all phases of development, including user studies.

At Abatek, a manufacturer of custom silicone keypads and input assemblies, worked with automotive, consumer goods and medical device companies to develop keypad concepts into manufacturable designs. Managed up to 20 projects at a time, working with factories in China, Thailand and Korea.Worked with a major insulin pump company to develop a new multi-layer keypad that met customer’s stringent assembly, reliability and cosmetic requirements. Wrote qualification protocols and report (IQ, OQ, PQ) for new UV molding process and equipment.Lead engineer for new product innovations. Project example: developed innovative design solution that combined light guide silicone and flex-membrane keypad for an electric vehicle home charging system.Responsible for Abatek’s technical marketing material. Created all of the content, text, layout and HTML code of Abatek’s online keypad design guide: www.abatek.com/designguide

Eaton | Airflex manufactures clutches & brakes for the oilfield, mining and manufacturing industries.1. Managed production schedule for one of the world’s largest clutches, making sure it would be ready for opening of new mine.

At Schlumberger, an oilfield services company, worked on two 3 month projects with the downhole deployment and monitoring group to solve real design and process problems.