This position is responsible for research, design and development of our X-Ray equipment, while providing support of installation and servicing of our equipment and training and technical support to our customers, dealers, and field engineers.

• Mechanical engineering design, prototype development and testing.
• Design specifications development based on requirements. Test methods development.
• Maintain the bill on materials for the X-Ray systems.
• Design transfer to production and supplier development and management.
• Technical investigations to ensure the highest level of customer satisfaction.
• Ability to train other engineers.
• Work closely with sales and customer service departments to ensure customer satisfaction.
• Work independently and also as part of the team.

ESSENTIAL FUNCTIONS/RESPONSIBILITIES

• Develop mechanical engineering design specifications based on requirements.
• Develop system and sub-system level test methods.
• Design, simulate, prototype and test new mechanical parts and improved revisions of existing parts following medical devices design control methodology.
• In partnership with Service and Support diagnose technical equipment conducting root cause analysis and propose improvement solutions.
• Mentor junior engineers and contribute to knowledge sharing withing the R&D group.
• Maintain tools and test equipment properly and ensure timely calibration.
• Complete and submit all required design control documentation on time and accurately.
• Completes assigned training and development courses assigned by management team.
• Provide emergency on-call services as needed in partnership with Service and Support.
• Serves as Service Representative for KMMI conventions and shows.
• Understands and Complies with all FSE Guidelines.
• Must comply with KMMI Radiation Safety Policy including the timely replacement of used badges.
• Completes the Corrective Actions Policy as prescribed by KMMI.
• Works toward complete satisfaction with every customer installation, break fix, and preventative maintenance visit.
• Displays highly developed organizational skills.
• Ability to prioritize, plan, and execute are key success factors in this position.
• Utilize exceptional interpersonal and communication skills for problem situations with customers and/or staff.
• Completion of additional projects and assignments as given by management.

REQUIREMENTS & QUALIFICATIONS

• Bachelor’s / Associates degree in mechanical engineering. Master’s degree preferred
• Certified Radiology Equipment Specialist (CRES) designation (www.aami.org)
• Certifications in Biomedical Equipment (CBET)
• Certification in Laboratory Equipment (CLES)

EXPERIENCE

• At least 8 years’ experience with medical devices mechanical design under design control, X-ray technologies a big plus.
• High proficiency in SolidWorks.
• High proficiency using 3D printers for rapid prototyping.
• Working knowledge of manufacturing technologies for plastic and metal for medical devices.
• Design control (MDSAP and ISO 13485).
• Risk management (ISO 14971).
• Usability of medical devices as it relates to safety (IEC 62366).
• X-ray physics and fundamental diagnostic X-ray imaging.