Equipment Engineer 2 (Medical Devices)

Location: On-site full-time in Durham, North Carolina, United States. Night shift: 10:00 p.m.–8:00 a.m., Wednesday–Saturday.

Company

hirify.global develops products and technologies in the regulated medical diagnostics and biotechnology space.

What you will do

• Analyze manufacturing equipment performance, identify reliability concerns, and develop data-driven improvement recommendations.
• Support the installation, modification, qualification, testing, calibration, and verification of laboratory manufacturing equipment and automation systems.
• Perform advanced maintenance, repairs, troubleshooting, and technical adjustments on complex equipment.
• Use root cause analysis and corrective actions to improve equipment reliability, capability, throughput, and performance.
• Create and maintain technical specifications, process instructions, test results, and engineering change records.
• Support preventive and predictive maintenance programs while ensuring safe, compliant, and efficient equipment operation.

Requirements

• Bachelor’s degree in mechanical, electrical, manufacturing engineering, or a related discipline.
• At least 2 years of relevant experience in equipment engineering, manufacturing, or maintenance engineering, or a master’s degree with 0–2 years of experience.
• Knowledge of automated manufacturing systems, control systems, and process instrumentation.
• Ability to read and interpret mechanical and electrical drawings and schematics.
• Familiarity with root cause analysis and FMEA tools.
• Knowledge of regulated medical device and laboratory standards, including GMP, ISO 13485, CAP, CLIA, NYSDOH, ISO 15189, IVDD, IVDR, FDA 21 CFR 800 series, and FDA 21 CFR Part 11.

Nice to have

• Strong problem-solving and analytical skills for diagnosing complex equipment and process issues.
• Experience collaborating across technical and operational teams.
• Ability to manage multiple assignments and adapt to changing priorities.
• Commitment to quality, safety, and operational excellence.

Culture & Benefits

• Work in a manufacturing and engineering environment with production equipment, machinery, moderate noise, and required PPE.
• Hands-on production-area support may involve standing, bending, or lifting equipment components.
• Occasional overtime or off-shift support may be required for critical maintenance or project activities.
• Benefits include flexible time off or vacation, a 401(k) plan with employer match, medical, dental, and vision coverage, and mindfulness programs.
• Additional compensation may include an annual bonus or incentives, subject to applicable plans and company discretion.