X-Ray Engineer (Medical Device)

JOB SUMMARY

The X-Ray Engineer will lead all engineering and production aspects of X-Ray Generation, including electrical high voltage design, glassware, heat management, and lean and quality production processes. They will work closely with R&D, QARA, and Production to architect, design, and develop next-generation X-ray generator assemblies, high-voltage subsystems, high-voltage insulation systems, and oil-filled assemblies from initial engineering concepts through final mass production. They will leverage advanced root-cause analysis and problem-solving techniques to translate research and development concepts into scalable, manufacturable, high-power hardware.

ESSENTIAL FUNCTIONS

• Own the electrical engineering design, conceptualization, and manufacturing transfer of X-ray generator assemblies, High-Voltage subsystems, High-Voltage insulation systems, and oil-filled assemblies, ensuring sound manufacturing methodologies are engineered directly into the initial layout.
• Develop technical solutions to achieve marketing/sales requirements to ISO13485 standards.
• Maintain and improve manufacturing processes, fixtures, work instructions, and acceptance criteria while designing and refining the underlying product architectures.
• Drive reliability improvements for X-ray generator assemblies, High-Voltage subsystems, insulation systems, and oil-filled assemblies by developing, implementing, and executing advanced, physical High-Voltage testing methodologies and validation protocols, ensuring all products are built, tested, and validated to IEC60601-1 4th edition standards.
• Identify and implement continuous improvement opportunities across processes, work instructions, product quality, and manufacturing efficiency to maintain statistical control of the production line.
• Troubleshoot manufacturing, assembly, test, and performance issues related to High-Voltage and X-ray systems, verbally collaborating across R&D, QARA, and Production to deploy rapid, permanent technical solutions.
• Own the entire generator technical lifecycle—from incoming parts and assembly processes through burn-in, clinical reliability, and field-return investigations.

BASIC QUALIFICATIONS

• Education: Bachelor's degree in Electrical Engineering (BSEE) or a closely related engineering discipline with a strong academic focus in Power Electronics, Electromagnetic Field Theory, or High-Voltage Physics. An advanced Master’s degree in Manufacturing Engineering or related disciplines is a plus.
• Experience: 3+ years of progressive electrical or hardware engineering experience designing, developing, validating, and implementing complex high-power or high-voltage (kV-level) electrical systems, with demonstrated expertise in product development and production readiness. 2+ years of progressive electrical engineering experience with demonstrated manufacturing engineering expertise, including manufacturing process development and new product introduction (NPI), is required, preferably in a medical device industry environment.

EXPERIENCE

• High-Voltage testing & process transition experience in engineering or production test engineering (preferably in the medical/industrial X-ray industry), with a proven track record of implementing sound manufacturing processes and safely configuring high-power test benches operating between 40kV and 150kV.
• Structured failure investigation experience leading structured root-cause analysis and problem-solving techniques to dissect generator breakdowns, electrical arcs, and contamination events from factory burn-in failures through clinical field returns.
• Cross-Functional technical communication: Demonstrated history of utilizing excellent written and verbal communication skills to bridge the gap between R&D, QARA, and Production—specifically transforming complex engineering requirements into audit-ready documentation and manufacturing work instructions.

CERTIFICATES AND LICENSES

• Mastery of specialized high-voltage test equipment, including digital oscilloscopes, high-voltage probes, insulation resistance testers, power analyzers, and partial discharge measurement systems.
• Comprehensive knowledge of high-voltage insulation systems, creepage and clearance design, dielectric breakdown, oil insulation systems, electric field management, and vacuum/altitude effects.
• Strong understanding of tube current regulation, filament and anode operation, dark current, tube aging, and tube vacuum behavior.
• Advanced proficiency in evaluating manufacturing processes to maintain strict control, determine process capabilities, design assembly fixtures, and establish compliant process validation (IQ/OQ/PQ) and acceptance criteria.
• Solid understanding of cleanliness and contamination control during assembly, with specific expertise regarding fluid contamination in oil-filled assemblies.
• Experience in applying structured reliability principles and problem-solving techniques to identify root-cause failures, evaluate field returns, and directly improve production yields.
• Experience in verifying products that meet regulatory/safety standards, using outside test agencies.