Richard Hales Email & Phone Number

Woodstock, Georgia, United States

Alpharetta, Georgia, United States

• Managed two Sr. Design Engineers and served as project lead for several multi-year product development efforts within Biologics R&D.
• Operational site lead for Stryker R&D facility based in Alpharetta, GA.
• Sole inventor of novel Class II medical device for harvesting high-volume autograft for long bone fractures (provisional application filed).
• Design lead for development of single-use instrumentation used for implantation of osteochondral allograft products in forefoot and ankle.
• Project lead and R&D SME for design transfer and manufacturing transfer activities associated with Cartiva implant and instrumentation products.

Alpharetta, Georgia, United States

• Designed composite implant for midfoot arthritis involving combination of PVA hydrogel, porous DMLS Titanium, and small bones hardware.
• Used patient CT scan reconstructions to develop unique instrumentation and operative technique for controlled preparation of midfoot joint surfaces.
• Developed dynamic 3D model simulating toe-off loading in forefoot and managed execution of various benchtop studies simulating biomechanics of 1st MTP joint.
• Developed and verified nonlinear FEA material model to simulate mechanical loading of various hydrogel compositions.
• Directed multiple HCP cadaver labs, including several successful remote surgical broadcasts providing virtual presence in accommodation for COVID travel restrictions.

Alpharetta, Georgia, United States

• Pioneered design and development of new synthetic cartilage implant and supporting instrumentation for the midfoot prior to onboarding additional engineering resources.
• Led HCP engagement activity for development team consisting of multiple, high-profile KOLs in the foot and ankle space.
• Designed and maintained development blog website to maximize level of engagement and sustain rich discussion with clinicians by providing project updates and sharing interactive 3D models, animations, and concept.

• Lead development of ultrasound-guided drug delivery system to automate peripheral nerve block injections and minimize risks of vascular penetration and nerve damage.
• Attended pitch meetings with executive team for business development initiatives serving as technical design lead and R&D spokesperson.
• Dictated functional requirements, designed graphical user interface, and managed component layout for multiple hand-built prototype injection devices.
• Designed single-use, pressure-regulating valve providing mechanical control of injection pressures during peripheral nerve block procedures.

• Managed contract manufacturer specializing in production of electronic medical devices, with particular focus on assembly of printed circuit boards, wire harnesses, and electro-mechanical sub-systems.
• Developed product training materials and conducted sales team training sessions.
• Regularly visited customer sites to observe procedures and to perform equipment installations, in-field training, and collection of user feedback.
• Managed contract medical device software development team utilizing collaborative SCRUM framework for bug fixes and new feature implementation.

• Supported commercialization and launch of 510(k)-cleared drug delivery device.
• Maintained design history and risk management files and coordinated planning and execution of verification and validation activities.
• Independently developed and authored first Safety Assurance Case reviewed and cleared by FDA under newly published guidance.
• Designed and coordinated on-site simulated use studies in accordance with FDA guidance for human factors and usability engineering.

Alpharetta, Georgia, United States

• Managed design and execution of mechanical testing performed on injection molded parts, UV-glued connections, and laser-welded assemblies.
• Coordinated ISTA/ASTM packaging and distribution test activities for electro-mechanical product assemblies and pouched single-use components.
• Supported laboratory testing for product safety and electromagnetic compatibility to establish conformance to UL standard 60601-1.