Consultant, Kevin Kennedy Associates Inc.
Providing project management, design engineering, electrical engineering, biomedical engineering, medical device product development, failure analysis,
forensic engineering, consulting and related expertise for a wide variety of clients.
Director of Development, medical device company
Provided development support for products used on cardiac tissue in both concomitant and closed-chest beating heart. Initially directed the QA function to re-establish that department and was transferred to Director of Development. Managed R&D department administration functions and planned work for seven engineers, techs and designer. Organized QA department to ensure company to meet QS hiring QA System Engineer, QA Tech and Doc Control Administrator. Wrote procedures to comply with design control and orchestrated all other quality procedure development. Managed QA personnel until new RA/QA Director was hired and transferred, at which 95% of the procedures were completed and department was fully functional. Was promoted to Director of Development, four direct reports and three indirect reports. Managed department budget $2+ million. Managed day to day activities, nurtured engineers in design control by writing procedures and providing training to them. Managed projects for several design enhancements to Laser, Controller and associated disposables. Developed new products for both lines. Developed technologies to enable closure of box lesion set as well as addition lesion sets. As part of the management team, was involved in the overall company strategy for bringing products to market, conserving cash runway and burn rates.
Project Manager, Design Engineer, Consultant
Provided clients with engineering management services, designed and developed medical device products including handheld disposables, resuables, and microprocessor control instrumentation utilizing solid modeling and schematic capture techniques. Managed all aspects of development projects, design control, product specification and quality plan preparation, product testing (materials, safety/effectiveness, lifecycle), and documentation. Developed and validated processes. Ensured compliance with regulations as well as 510(k) filing guidelines. Solved mechanical design problem with an implantable inserter for Restore Medical and managed new design of the device to reduce costs and increase profits. Established design control systems to enable numerous companies to obtain ISO 9000 certification.
Senior Project Engineer, Advanced Engineering, Endosurgery, Davis & Geck Inc.
Project manager for fast-track commercialization of new endoscopic instruments; ensured adherence to strict schedules, with time-to-market for a main platform set at ten months and line extensions at two months. Led technicians and engineers; prepared schedules for product development and testing, including destructive and life testing. Assessed OEM vendor capabilities to ensure alignment with the company's marketing plan. Established and directed technicians within an instrument repair department. Designed and patented an electrosurgical safety boot for use on endoscopic dissectors.
Senior Project Engineer, Research and Development, Valleylab, Inc.
Project manager responsible for launching new and improved ultrasonic surgical aspirator products to market utilizing a project team concept. Led the improvement of existing designs to increase reliability and profitability. Coordinated the release of over eight products that generated sales of over $35 million. Designed and implemented the disposable steam/ETO sterilizable product line and co-designed a steam/ETO sterilizable straight and angled handpiece as well as a switching mechanism.
