Medical Device & Biotechnology Systems Engineer
professional summary
A System Engineer with over 12 years of professional experience working primarily in the Medical device industry. Experienced in development and commercialization of bioresearch and medical equipment. Instrumental at developing documentation control for engineering, manufacturing, and service support operations. Excellent communicator with exceptional problem solving skills that have always exceeded internal and external customer expectations.
technical skills
• M.S. Office Suite
• M.S. Project
• MatLab and LABView
• Solidworks • MathCadd
• CST Microwave Studio
• Lasers
• HPLC Pumps • CE/IEC Requirements
• FDA regulations
• Doors, Clearcase, and ClearQuest
• Familiar with AX and SAP
career history
Accuray (formerly TomoTherapy), Madison, WI 2005 - Present
Group Lead / Architecture Team Lead 2011 – Present
• Lead Hardware systems Architect for multi discipline cross-functional team for radiation therapy equipment.
• Cross-functional teams that include Manufacturing, Service, Software, Electrical, and Mechanical Engineers.
• Design Authority (Lead Engineer) for multiple projects, which included managing direct and indirect reports.
• Member of special high-level RF design team.
• Develop Linear accelerator specifications and qualification
• Develop technical specifications and qualifications for medical equipment hardware.
• Develop system design and architect for medical radiation therapy equipment.
• Participated in qualification and technical review of a manufacturer purchased by the company in China.
• Responsible for coordinating engineers and technicians for development projects.
• Responsible for reviewing internal and external customer requests as part internal product feedback team.
• Responsible for translating non-engineering requirements to engineering requirements.
Senior Systems Engineer 2007 – 2011
• Responsible for several major projects, including cost down projects for Linacs and RF System.
• Developed onboard oscilloscope system for operational diagnostics.
• Developed qualification of parts to allow alternate or multiple sourcing.
• Develop and test radiation shielding systems for therapy systems.
• Participated in and lead peer level and formal design reviews
• Participated in and hazard reviews.
• Develop service support hardware and procedures.
• Develop hardware upgrade procedures for feature enhancements.
• Drove consumption of key RF components down 50% leading to significant reductions in service cost.
Service Solutions Engineer 2005 - 2007
• Provided Top-level service support for service escalations.
• Developed instructions, tools procedures, training information.
SpectruMedix, LLC, State College, PA 2001 - 2005
Senior Engineer / Production Manager 2003 - 2005
• Responsible for multiple direct reports including: technicians, machinists, engineers, and assemblers.
• Responsible for product shipping and hardware development.
• Assumed responsibilities within a failing project and drove to successful completion of all requirements.
• Control system programming for bioresearch equipment.
• Supervision of production personnel for released produc...
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