Leading development of a novel cervical brachytherapy class II medical device

Working with a cancer startup to improve patient outcomes with a novel medical device.Working to set product requirements, hire an engineering team, manage that engineering team, set strategy and support other company goals.

Fractional engineering management (fCTO/fVP/fDirector/fManager/PM) for Med Dev and hard tech startups and full service PDaaS

Bayard Design provides engineered solutions to our customers’ product design projects. Our team can run your project from concept to design to launch to sustaining. We bring the latest best practices and techniques to bear on your product.As founder of Bayard Design Matthew has:- Managed an in-house team of 8+ workers - Program Managed design efforts with budgets of $1kk+ including in-house, customer and third party Industrial Design, Electrical Engineering and Software resources- Managed and planned vendor and contract manufacturer relationships- Handled all aspects of recruiting and internal business systems- Set up customer PDM solutions and quality systems including those used as part of a FDA compliant customer ISO 13485 quality system

Designed a custom hybrid electric drive system for a flying car including mechanical design/FEA, thermal analysis/CFD, system engineering, component selection and prototype development/testing.

Led a team of engineers, designers and an industrial designer to develop a next generation articulating arm; Participated in system level development of a next generation robotic vascular surgery assistance device; Developed a human factors based multi-variable verification model to simplify design and verification; Engineered a short lead time articulating arm for beta testing of other system components

Integrated a new lung transport system into an existing heart transport system; Led prototyping efforts from proof of concept to alpha to beta to IDE units; Designed a novel solution to minimize disposable costs and make the non-disposable unit easy to clean; Engineered an ultra-light weight, reliable portable ventilator for use with transported human organs; Prepared engineering documentation for CE and FDA device approval; Administered CE and internal product testing; Led development of a light weight, low power, multi-channel infusion pump

Lead engineer for a novel wireless “man-wearable” heart rate and respiration monitor for military training use; Lead engineer for solider locator project that fielded prototypes in only 4 months with US Special Forces units; Managed a China based design and manufacturing team producing a consumer targeted heart rate and resp. monitor; Implemented vaulted PDM solution to create device history record; Integrated sealed, rugged electronics packages with comfortable fabric garments

Engineered critical components and systems for a transport system for human lungs for transplant

Brought in to augment the internal team:- Assisted in 3D modelling of complex professional sport helmets for injection molding- Laid out man-wearable wiring harnesses for Future Force Warrior- Assisted in preliminary design of the Wing-Loc Adapters for the OpsCore ACH ARCS helmet rail system- Finalized the waterproofing and design for injection molding of a reusable no touch waste disposal barrel

Consulted with a variety of customers on cutting edge consumer, medical and military products

Lead engineer for digital safety sensors for major automotive customers including domestics and transplants; Designed injection molded plastic and stamped metal parts to strict cost requirements; Assisted in PPAP process as a Tier I, II or III supplier, including FMEA, DFMA, Lean, DFSS, Six Sigma, etc.; Worked with sales and marketing to define customer requirements during customer visits; Qualified products to customer and agency specifications and tests, such as ISO, JASO and SAE; Created and implemented internal qualification tests and analyses where appropriate including FEA and DOE; Worked with domestic and off shore suppliers to develop cost effective components and processes

Engineered Tier 1, 2 and 3 automotive components

Lead engineer for a new OEM electromechanical product with an expected volume of millions of units; Assisted off shore manufacturing with product launch; Designed injection molded plastic and stamped metal components; Worked with purchasing in materials selection and vendor selection; Worked with global regulatory bodies to gain product certification; Assisted sales and marketing with new customer engagement and application support

Engineered electromechanical refrigerator components