Medical device engineering consulting specializing in novel, early-stage technologies. I continue to be interested in efficient design, design for manufacturability, requirements development and traceability, and risk mitigation.

Led the development of transapical delivery system for a novel prosthetic mitral valve. Refined existing design and outsourced follow on development work, managing responsible design firm.Performed ground-level design on transseptal delivery system, involving collection and interpretation of anatomical models to optimize trajectory and usable space.Developed a valve stretching device to prepare the valve for insertion into either the transapical or transseptal system.Developed top-level to detailed design requirements for the delivery system, established traceability among requirements, developed test plan.

Led a team of engineers and technicians to manufacture and distribute a steerable intravascular catheter used to treat ventricular tachycardia, supporting demands of regulatory feasibility study.Iterated the catheter and handle designs to reduce profile, improve steering, and improve control layout.

Served as technical lead on a novel facial dermatology platform, consisting of a console and hand-held unit designed to rapidly heat and cool target tissue. Organized engineering work and proposal, communicated with client.Managed technical effort on tissue oximetry products used to assist physicians with mastectomy surgery and bowel resection. Led team in the development of a reusable oximetry module that couples into an inexpensive, disposable hermetic sheath. Managed requirements traceability through definition to verification, organized resources, drove design and development work.Supported technical effort on a “smart” pill used to focus medicine delivery to the upper region of the small intestine. Specified power requirements, board layout, micro-molded pill body, and assembly.

Research and Development manager responsible for technical improvements to the MitraClip mitral valve repair system. Led engineering team to improve handle control systems. Created steering improvements to improve steering predictability. Implemented machined-to-molded design changes to reduce COGS and improve assembly.

Directed R&D effort in a small, VC-stage start-up to develop a novel adjustable annuloplasty ring for the mitral valve. Worked with physicians on product requirements, oversaw day-to-day development and manufacturing transfer. Led product from initial concept to European Clinical in 12 months. Led manufacturing transfer and validation activities leading to product launch.Supported 55-patient OUS device clinical study at centers in Germany, Holland, and Italy. Conducted on-site training with study physicians and participated in surgical implantations of the device.Participated in intellectual property development for MIS application of device, as well as post-operative and long-term device adjustment. Directed engineering efforts on MIS platform.

Research and Development engineer at Guidant's Cardiac Surgery division.Led a team of 12 to develop a convertible cardiac microwave ablation device. Solicited user needs, managed requirements and schedule. Drove product from concept to pre-clinical testing in 15 months.Led cross-functional team to market-release improved low-profile OPCAB stabilizer device with significantly reduced cost from prior generation. Developed marketing requirements with product manager. Guided 3 R&D engineers in their work. Worked with Operations to develop manufacturing line.Project engineer on the Guidant OPCAB platform. Contributed to designs of XPose III, Vacuum II, and Mechanical Stabilizers. Prototyped design concepts, participated in design reviews, designed components for manufacture, interfaced with vendors, contributed to project management and schedule discussions.Supplier Quality Engineer dedicated to Guidant (EVT) AAA device. Processed line-down material, worked with vendors to improve manufacturing techniques. Issued and resolved supplier corrective actions.

Oversaw Lockheed Martin team’s technical performance on $5.2B MILSTAR satellite program. Identified manufacturing process issues and drove resolution. Assisted with contractor’s implementation of ISO 9001.Managed hardware and software configurations for $200M of flight simulators and associated training equipment. Authored statements of work, managed technical specifications, budgeted for future efforts.