Principal Reliability Engineer — Medical Devices

BioCT Innovation Commons; North Haven (CT); On-site; USD 132,000 - 198,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan with match

Tuition assistance

Job summary

Medtronic is seeking a Principal Reliability Engineer to join the surgical operating unit within the new product development quality team. You will lead reliability strategy development for medical devices, conduct HALT/ALT testing, and collaborate with R&D to strengthen design robustness and regulatory compliance.

The role requires a strong background in reliability science, design controls knowledge, and the ability to mentor cross‑functional teams in a fast-paced environment.

Qualifications

• Bachelor’s orMaster’s degree with 5–7 years of relevant experience.
• Experience developing reliability strategies for new medical devices and products.
• Knowledge of design controls and regulatory requirements (FDA/ISO).
• Ability to lead cross‑functional teams and mentor others.

Responsibilities

• Develop reliability plans and identify activities during product development.
• Perform HALT/ALT and other reliability tests.
• Collaborate with R&D to design reliability tests and identify design weaknesses.
• Support test method validation, protocols, and reports.
• Provide post‑market reliability analysis and field data review.
• Ensure compliance with FDA and ISO/IEC standards (14971, 13485, 62304, 820, IEC 60601).
• Lead and mentor reliability processes and teams across programs.

Skills

Reliability engineering

Team leadership

Statistical analysis

Regulatory knowledge

Education

Bachelor's Degree in Mechanical/Electrical Engineering or Reliability Engineering

Master's degree in Mechanical/Electrical or Reliability Engineering

Tools

ReliaSoft

LabVIEW

Sherlock

Job description

Medtronic is seeking a Principal Reliability Engineer to join the surgical operating unit within the new product development quality team. You will lead reliability strategy development for medical devices, conduct HALT/ALT testing, and collaborate with R&D to strengthen design robustness and regulatory compliance.

The role requires a strong background in reliability science, design controls knowledge, and the ability to mentor cross‑functional teams in a fast-paced environment.