The Service Engineer supports all technical aspects of the Cook Capital Equipment service business relating to product knowledge, service expertise, and continuous improvement.
• Follow and create service procedures and comply with requirements of 21CFR Quality System Regulations, ISO 13485 and ISO 14971
• Perform repair and preventive maintenance work on Cook Capital Equipment products
• Hands on work, troubleshooting, repairing, building electronic medical systems
• Manage complaint and technical assessments
• Interface with OEM on replacement parts and replacement part changes
• Assist quality engineering in evaluating failures with devices
• Utilize engineering knowledge and technical expertise to execute project work
• Prepare and maintain accurate documentation of concepts, designs, drawings, and manufacturing processes consistent with the requirements of pertinent regulations and Cook’s Quality Management System
• Service field service technicians for advanced troubleshooting
• Maintain and increase technical, medical and biomedical development knowledge related to the company’s product lines
• Maintain accurate and timely reports and records
• Analyze device service history
• Bachelor's degree in Engineering, plus a minimum of 5 years work experience in electronic medical device development or medical device servicing; or a Master’s degree
• Electronics and laser technology engineering experience required
• Comprehensive knowledge of mechanical engineering principles, mechanical properties testing, mechanical design and theories
• Previous project management experience preferred
• Basic knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
• Strong hands on skills and mechanical abilities
• Experience with Microsoft Office, PowerPoint, Excel, Word, Outlook, Trackwise, jBase, Product Lifecycle Management, MRP
• Strong Project Engineering Experience in:
• High power NIR surgical lasers; preferably Ho:YAG
• Electronic medical equipment
• Silica Holmium Laser Fibers
• Electronic metrology and theory
• Subject to reasonable accommodation requirements under the ADA, must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle
• Travel up to 25%
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