Consider these qualifications.
Mr. Keen ran engineering groups that matured medical prototypes into production. He has developed over two hundred "designs from scratch". Mr. Keen managed large engineering groups on the Hubble Space Telescope and built fighter plane weapons systems. As the cold war ended, Mr. Keen joined others to form Compliance Consultants. His background is mixed with Fortune 100 corporate management as well as struggling inventors. He is comfortable in complex, highly regulated environments and high performance technologies.
Richard Keen's resume
Objective: To use my experience in regulatory affairs and product engineering to take new medical devices, clinical trials, and associated documentation systems through the ordered, rigorous process of achieving FDA {EC}clearances and maintaining production a wide variety of products.
Compliance Consultants. Work for principal inventors worldwide, clients obtained on referral basis. Consult and advise clients concerning regulatory compliance. Create regulatory strategy and submit device applications to the FDA. Plan, manage and implement detail designs {electronic, computer, software, mechanical, optical, micro mechanical, catheter, human implant, material science, fluid systems, tubing sets, sterilization systems and drug delivery systems}. Organize and define engineering programs and documentation systems. Define and organize the design efforts from proof of concept devices to ensure design complies to FDA {& EC}regulations, performance standards, test requirements, maintainability, produceability and repeatability. Created documentation necessary to define, test, manufacture, maintain, and revise complex systems. Audited Quality Systems. Submitted over 100 projects to the FDA. Work on a fixed-fee basis to implement such programs from inception to completion. {1989 to present}.
Norden Systems {Division of Grumman Northrop} Senior Development Engineer. Ran major technical projects as part of a billion dollar airborne weapon systems program. Negotiated a highly propriety contract to acquire an imbedded, custom built scalar computer to acquire and track multiple-targets. Negotiated a contract with an elite "think tank" who originated a solid state high frequency phase shifter which was embodied in the J-Stars antenna system and used in the Gulf War. Negotiated a highly propriety contract with the Israel Air Force to acquire intellectual property. Planned and organized the integration plan for a multi-processor and program, mission and test software. Defined automated testing. {1985 to 1988}.
Perkin-Elmer (Hughes Optical Group). Manager of Engineering Support. Managed 135 professionals, a 15 million budget and project schedules on complex programs {such as the Space Telescope} to deliver classified {black & secret} systems for classified customers. Planned long-term department strategy and ran daily operations, responsible for staffing, budget and establishing policy. {1984 to 1985}.
Raytheon Medical Imaging. Manager of Design & Documentation. Managed group of 35 engineers who are assigned the task of taking x-ray research and development hardware/software prototypes through the transition from engineering models to manufacturing, including all regulatory and documentation required to develop and support the product {both manufacturing and in the field}. Responsible for all detail redesign {mechanical, electronic, software, safety, etc.} to ensure final device meets FDA/UL regulations. Managed development activities on a daily basis. Submitted or maintained hundreds of devices scrutinized by the FDA. Developed over a hundred "designs from scratch" in the early days of medical imaging. Ran Preliminary/Final Design reviews on projects. {1980 to 1984}.
Education:
Engineering School: University of Texas
Graduate Marketing: University of Bridgeport
Compliance Consultants