Reliability Engineer – Quality Systems

About the role

The Reliability Engineer will develop and maintain quality systems for manufacturing processes, ensuring product reliability and compliance with medical device standards.

Key responsibilities

• Develop and coordinate technical reliability studies, design of experiments (DOE) and risk analyses for new designs and processes.
• Review engineering drawings, initiate changes to gauging and inspection procedures, and document all changes in the Manufacturing Engineering control system.
• Conduct PFMEA, statistical process control, and performance reporting to identify and mitigate failure risks.
• Design gauges and fixtures, lead gauge design reviews, and improve in‑process inspection methods.
• Lead technical quality reviews of suppliers, recommend equipment upgrades, and mentor other engineers in quality practices.

Required profile

• Bachelor's degree in engineering (or higher) with at least 7 years of relevant experience; advanced English proficiency.
• Experience in the medical device industry and familiarity with regulatory requirements.
• Ability to travel as needed.

Required skills

• Statistical analysis tools (Minitab or equivalent).
• PFMEA, DOE, risk analysis, and statistical process control.
• Gauge and fixture design, GD&T.
• ASQ‑CQE certification, Lean Six Sigma Green Belt or higher.
• Advanced Microsoft Excel and PowerPoint.