Medical Device Service Engineer

Job Title:

Medical Device Service Engineer

Location:

Madison, WI (Additional Locations)

The Medical Device Service Engineer combines hands‑on technical work with clear, accurate documentation and technical writing. The role supports customers, internal teams, and regulatory needs while ensuring compliance with regulatory, quality, and good documentation standards. The engineer provides guidance and support for service methods, tooling, equipment, test systems, troubleshooting, and repairs of medical devices.

• Master all Service Technician requirements, including Evolve Service Log analysis.
• Train new Service Technicians at all levels.
• Create or update service procedures and manuals as part of the change‑control process.
• Support medical device design controls from a Service perspective.
• Assist with new device launches regarding Service requirements.
• Define and update the ERP process for recording Service documentation.
• Utilize existing utility, workflow, and business‑demand metric reports to manage the service workflow.
• Serve as a technical expert on the current service process and requirements.
• Manage or participate in related project work as assigned.
• Ensure compliance with quality, safety, and regulatory initiatives.
• Perform installation, calibration, preventive maintenance, and repair of medical devices and related systems.
• Diagnose technical issues using electronic, mechanical, and software‑based troubleshooting methods.
• Document service activities clearly, concisely, and in a compliant manner.
• Maintain adherence to GxP, ISO, and company quality system requirements.
• Collaborate with engineering, quality, and product teams to resolve issues and support continuous improvement.
• Follow all safety protocols and maintain a professional presence in clinical and laboratory settings.
• Develop and revise service documentation (SOPs, WIs, SBs, Process Flow Diagrams, and other quality documentation) as necessary.
• Support all service methods, tooling, preventive maintenance, equipment calibration, test systems, and documentation ensuring regulatory compliance.
• Work closely with Manufacturing Engineering, Sustaining Engineering, and GDE to improve service processes and design for serviceability.
• Train Service Associates on new and/or revised service processes, equipment, and documentation.
• Proficient in standard office software (MS Word, Excel, etc.).
• Work scheduled/expanded shifts, holidays, and/or off‑shift duties as required.
• Perform other duties as required to meet business needs.

• Bachelor of Science in Engineering (preferred). Minimum of a two‑year technical degree in electronics, biomedical engineering, mechanical engineering, or related discipline (or military equivalent) with 5+ years of electromechanical maintenance experience.
• Minimum of 1–3 years of experience servicing medical devices, laboratory instrumentation, or comparable electromechanical systems.
• Demonstrated experience in technical writing, including preparation of service documentation, SOPs, or technical reports.
• Familiarity with GxP processes (GMP, GLP, GCP) and experience in regulated environments.
• Strong analytical, diagnostic, and problem‑solving skills.
• Proficiency in reading schematics, using diagnostic tools, and working with software‑driven devices.
• Effective written and verbal communication skills with the ability to interact professionally with customers and internal teams.
• Ability to travel as required to support service operations.

• Experience with FDA‑regulated medical devices or ISO 13485 environments.
• Knowledge of networking, device connectivity, or software‑driven instrumentation.
• Certification in biomedical equipment technology (CBET) or similar credentials.
• Microsoft Office and SAP Service module (SM) proficiency.
• Proficiency in the Keenova service model for the INO
  
  max platform.
• Experience conducting training classes.
• Detail oriented, excellent written and oral communication skills.
• Ability to analyze, prioritize, and manage multiple tasks.
• Technical analysis and evaluation, root cause analysis, and problem resolution.

Office environment, manufacturing/servicing floor, and Regional Service Center service areas. Approximately 20% travel may be required.

Keenova provides equal employment opportunities to applicants and employees without regard to race, color, gender, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, disability, or any other category protected by law.