Joined an early-stage medical device company with responsibilities encompassing Quality, Regulatory, Engineering, and Operations/Manufacturing. Led the way in the construction of an ISO 13485-compliant Quality Management System from the ground-up while supporting work to achieve US FDA 510(k) clearance of our first product in 2015. Grew staff and established initial manufacturing capabilities to support revenue generation. Implemented management systems in support of design services projects to augment revenue and enhance customer satisfaction. Once growth achieved levels that reached the limits of our current space, led the search for and move to a new facility in 2018 which positions the company to accommodate planned growth.

Responsible for all R&D, product support, quality and regulatory activities for the US site of a global manufacturer of dental products. Products range from small, high-precision ground and machined parts up to tabletop electromechanical hygiene and electrosurgical devices. Provided leadership, guidance and coaching to a team of 20+ technical professionals. Implemented a standardized global NPD process across multiple sites, improved adherence to FDA design controls, initiated research partnerships with universities, reduced employee turnover and significantly improved attention to detail and document management practices.

Responsible to plan and direct all aspects of Engineering R&D activities for the development of accessories for liquid chemical sterilization systems, including STERIS’s flagship sterile processor (SYSTEM 1®). Provide leadership, mentoring and technical expertise in support of a staff of eight engineers, designers, technical writers and graphical designers. Work directly with various functions globally to respond to Customer and market needs. Develop and support group practices in compliance with FDA and ISO standards.

Led the design and implementation of a multi-million dollar Windchill PLM system at several worldwide locations, acting as both project manager and business process owner. Accomplishments included numbering and versioning standardization for parts and documents, engineering change process consolidation, data migration of parts, BOMs and associated documents, system configuration to business requirements and FDA system validation. Successfully coordinated the activities of team members in a non-project structured business. Developed and applied a training program for several hundred users. After PLM, led a cross-functional product development project coordinating the engineering and scientific feasibility activities for a new sterilizer system. Responsibilities included project management, reporting to stakeholders, requirements documentation, technical review of concepts and issue resolution.

Led a design team responsible for the development, validation and release of a line of accessories for STERIS's flagship sterile processor (SYSTEM 1®). Directly supervised three designers while coordinating with a cross-functional team to deliver sterile results and a quality product. Worked with various plastics and grades of stainless steel. Utilized press-fits, snap-fits, adhesive bonding, laser marking, water cutting and high-precision machining processes to prototype parts and specify manufacturing methods for production.While in this position, I recognized a need to improve the way we manage our product information. This led to a lengthy investigation into PDM and PLM solutions, and my eventual proposal to implement a PLM system at STERIS. Upon acceptance of the proposal, I initiated a structured vendor comparison activity, helped to negotiate a statement of work, and began leading a project which was destined to change the way we managed our product information.

Active member of a large team working to develop new sterile processors for healthcare facilities. Split time between design work and the development, documentation and implementation of LabView-based data acquisition systems to both run and record data for prototype sterile processors. Design responsibilities ranged from pumps and fluid handling system design to the development of a new stabilization and transport system for the devices which were to be processed.

Participated as a design team member for several capital projects. Developed a new chemical delivery mechanism for a fluid waste handling product and assisted in troubleshooting manufacturing and performance issues for a sterile processor intended for the dental market.