The Service Engineer supports all technical aspects of the Cook Capital Equipment service business relating to product knowledge, service expertise, and continuous improvement. Responsibilities include following and creating service procedures and complying with requirements of 21CFR Quality System Regulations, ISO 13485, and ISO 14971. The role involves performing repair and preventive maintenance work on Cook Capital Equipment products, hands-on work troubleshooting, repairing, and building electronic medical systems, managing complaint and technical assessments, interfacing with OEM on replacement parts and replacement part changes, and assisting quality engineering in evaluating failures with devices. The engineer utilizes engineering knowledge and technical expertise to execute project work, prepares and maintains accurate documentation of concepts, designs, drawings, and manufacturing processes consistent with the requirements of pertinent regulations and Cook's Quality Management System, services field service technicians for advanced troubleshooting, maintains and increases technical, medical, and biomedical development knowledge related to the company's product lines, and maintains accurate and timely reports and records. The engineer analyzes device service history.
Qualifications include a 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 is required, along with comprehensive knowledge of mechanical engineering principles, mechanical properties testing, mechanical design, and theories. Previous project management experience is preferred, as is 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 are necessary, along with 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 is required. The candidate must be physically capable of operating a motor vehicle on a regular basis, a holder of a valid driver's license, and in good standing to legally operate a motor vehicle. Travel up to 25% is required.