Leading a small team of engineers in a race to bring an exciting new restorative vision treatment to market.Using 40 years of product development experience to provide mentorship and an environment that allows people to flourish.Putting creative problem solving to work in a challenging technical space.Helping build, document, and deceminate processes into the business as we grow.

Currently helping to take portable real-time DNA/RNA analysis instruments and consumables to market and having a lot of fun.

• Worked as part of team to transfer a highly automated/complex laboratory diagnostics product into production in accordance with FDA CGMP (21 CFR, part 820).• Hosted meetings between R&D engineers, vendors, and procurement to educate our staff with respect to various processes and the capabilities of those processes.• Processed non-conforming materials through quality notifications.• Collaborate with various stake holders on pFMEA’s and the creation of work instructions. • Worked with SAP, NX, TeamCenter, and Right Hemisphere throughout the project for processing change requests, engineering changes, pFMEA’s, temporary manufacturing deviations, and work instructions.• Coached junior engineers on geometric tolerancing and understanding tolerancing from the perspective of manufacturers and inspectors.

• Run design firm with focus on stylish yet well-engineered products.• Products include toys (Power Glove for Mattel), eye wear, skateboard and snowboard products, medical equipment, consumer electronics, and office equipment.• Developed alternative skateboard that was featured in the “San Diego Business Journal”.• Completed structural analysis using SolidWorks and COSMOS for recent large statue installation in Center City Philadelphia.• Consulted with Vention, a product development company whose focus was catheters. Provided R&D and problem solving support to get them over a process development hurdle.• Helped Terumo, a medical device company, while they were under FDA consent decree. Reviewed device claims, verification reports, and validation reports. Wrote test plans, designed fixturing, and ran tests.• Developed embedded fire sprinkler alarm system from the ground up for AGF Manufacturing, Inc.• Currently developing new miniature linear actuator technology that could revolutionize the motion industry.

• Led engineering effort on high-end office furniture including lounge and task seating and tables.• Performed and documented verification testing on seating and table products per BIFMA standards.• Performed FEA (COSMOS) on furniture in the early phases of product development to determine deflections under loads.• Managed root cause analysis investigations when quality issues arose.• Worked with SolidWorks (CAD), BobCAM, V-Carve, and WoodWOP (CAM) and two CNC routers to fabricate plywood frames for new lounge chair product lines.• Collaborated closely with inside and outside design professionals.• Managed the tooling up and troubleshooting of die cast, stamped, and injection molded components in China.

•Managed a staff of a dozen engineers, artists, and craftsmen in their engagement with NextFab clients.•Provided technical and business guidance to the staff.•Shared responsibility for running company-wide meetings.•Helped create and edit company policies and processes.•Met and worked with clients.•Helped manage the facility.•Shared HR responsibilities.

• Assisted in the design, manufacture, and verification of a high throughput slide scanner for the field of digital pathology. • Contributed to the writing of product specifications, production work instructions, and in-process test procedures. • Helped transfer product from development to manufacturing. • Designed, sourced, and assembled production tooling. • Received training in optics systems, including the alignment and cleaning of such systems. • Researched and sourced materials, finishes, and processes to facilitate the completion of production level documentation. • Collaborated with optics, electrical, and software engineers, as well as scientists, testing houses, engineering consultants, and ID firms. • Used IEC 61010-1 to define safety requirements and IEC 61326-1 and CISPR 11 to define EMC requirements.

• Helped lead the design of a key product in the field of electrophysiology; focus was on human factors and thorough adherence to IEC 60601-1. • Designed robust metal/plastic enclosure that housed two backplanes, a mix of nine analog and digital PCI/ISA cards, and power and I/O electronics.• Collaborated on design of seven unique PCB's, six unique flex-circuits, twenty internal and external (patient-side) cables, dozens of connector interfaces, and all product labeling.• Responsible for selecting all materials, finishes, and manufacturing processes.• Created all documentation required to manufacture product other than PCB design files (Gerbers).• Played vital role in conceptualizing product, ID, authoring requirements, project planning, design reviews, verification testing, risk management, and RoHS and WEE compliance.

• Provided guidance to ID firm in early stages of product development.• Worked side-by-side with firmware writers, RF engineers, electrical engineers, technicians, marketing, and outside contractors to develop sixteen distinct wireless home security products in two years.• Navigated language and cultural differences and a thirteen hour time difference in daily teleconferences with our Chinese contract manufacturers.• Ensured compliance with regulatory agencies including UL, CSA, and the FCC.

• Led effort to uncover root cause of a leaking spinal needle that precipitated a product recall and threatened to shut down 70% of the global supply of this needle type.• Managed short-term solution to bring BD's current production process into spec and long-term solution to redesign the product and implement new tooling at three production facilities.• Held weekly teleconferences and maintained detailed project schedule, complicated by two sets of tooling in two countries producing ten different needle gages.

• Implemented the design, documentation, and verification of lower half of anesthesia machine intended for world-wide sales. These were Class II medical devices and had to meet the diverse needs of doctors and anesthesiologists from the US, Japan, Canada, and Europe as well as be configurable for three separate installations: wall-mount, ceiling mount, and floor.• Designed 35 pound structural foam base, storage drawers, welded tubular frame, electronics enclosure, and ergonomic central brake system.• Performed structural analysis of welded frame with COSMOS Finite Element Analysis (FEA) software.• Designed tests and testing fixtures to determine life of critical components.

• Time was spent conceiving new product platforms, developing custom products for clients, managing multiple projects, mentoring entry and mid-level engineers, costing, modeling (SDRC and SolidWorks), doing structural FEA with COSMOS and SDRC, prototyping (50% done by myself in Southco's toolroom), testing (done by myself in Southco's testing lab), and working with suppliers and Southco's manufacturing facilities.• Developed thirty new concepts into working prototypes in my first three years at Southco. One of these ideas became the basis of a six-person product development team with a $1.4 million development budget.• Developed products with Cisco, HP, Sun Microsystems, EMC, Nortel, Lucent, and IBM.• Worked closely with manufacturing on stamping, injection molding, diecasting, cold heading, thread rolling, screw machining, progressive forming, heat treating, plating, powder coating, and several types of automated assembly.

• Took two video gaming products from concept to production in two years. • These gaming machines were the top grossing products in their class worldwide and were comprised of a 13” VGA CRT, touch screen system, cash system, and PC computer system in a single housing. These systems were packaged in a compact, rugged, attractive, safe (UL approved), manufacturable, splash-resistant, flame retardant, cool, clean, well grounded, well shielded (EMI safe), and secure enclosure.• Focused on designing the products with the concerns of the gamer, establishment owner, and route owner in mind.• Engineering drawings were done with AutoCAD, r13. Industrial design and design of injection molded parts was handled with SolidWorks.

• Developed new coffee brewer that reduced the part count by 35% and cost by 25%.• The new design eliminated the two most often replaced wear parts and reduced service hours required to maintain the machine. Redesigned humidity control system, eliminating seven parts from a twelve-part assembly. The savings in material cost alone was $17 on a $42 assembly.• Designed other major sub-systems including the cup dispenser and user interface. Many parts were manufactured in-house using CNC turret punches, brake presses, spot welders, and high speed fastener systems.• Designed injection molded parts in nylon, ABS, polypropylene, and thermoplastic elastomers. Also, advised engineering department head on matters of product aesthetic and human factors.

• Helped develop satellite-borne imaging instrument that provided time-tagged X-ray images of pulsars (stars) for NASA's explorer program.• Designed, developed, and coordinated the manufacture of aiming mechanisms, for the instrument meeting demanding specs for stress, temperature variation, vibration, tolerances, mass properties, and mechanism dynamics. • Fabrication included conventional machining, gear hobbing, vacuum sputtering, wire EDMing, nitriding, dry films, chemical films, and carbide surface treatments. • Specified materials, bearings, gears, fasteners, splines, coatings, lubricants, surface finishes, and tolerances. • Responsibilities also included scheduling and tracking, instrument assembly, inspection, testing, costing, purchasing, and managing a technician.