Principal Reliability Engineer-Medical Device Development

Principal Reliability Engineer – Medical Device Development Job Description

Overview: The Systems Reliability Engineer is responsible for ensuring the long‑term performance, robustness, and durability of medical diagnostic instrumentation. The role focuses on reliability modeling, lifetime testing, failure analysis, and continuous improvement of modules, sub‑assemblies, and overall medical instruments. The engineer works cross‑functionally with R&D engineers, manufacturing, quality, and customer R&D and field service teams to enhance product reliability across the full lifecycle.

• Develop and implement reliability plans for medical instrumentation.
• Define reliability requirements and qualification criteria based on customer requirements and industry standards.
• Perform reliability allocation and prediction (MTBF, FIT rate analysis).
• Develop reliability growth plans and tracking metrics.
• Conduct reliability analysis (Reliability Predictions, Failure Mode Effects and Criticality Analysis), maintainability analysis (Mean Time to Repair, Mean Time Between Maintenance), and testability analysis (Built‑In Test).
• Design and execute accelerated life tests (ALT, HALT, HASS) – module and systems levels.
• Conduct environmental testing (thermal cycling, humidity, vibration, shock).
• Develop stress screening procedures for electronic and mechanical assemblies.
• Lead root‑cause analysis on development & production instrument/module failures.
• Apply structured methodologies (FMEA, 8‑D, Fishbone, Weibull analysis).
• Work with suppliers to address component‑level reliability issues.
• Collaborate with R&D during product development to improve thermal management, mechanical stability, and recommend material and component upgrades to extend lifetime.
• Analyze field and test data using statistical tools, perform Weibull and life‑data analysis, and maintain reliability databases.
• Support field service teams in diagnosing complex failures, analyze warranty trends and customer feedback, and provide technical reports on reliability performance.

• Bachelor’s or Master’s degree in Electrical Engineering, Physics, Systems Engineering, Mechanical Engineering, or related field.
• 8 or more years of engineering experience, including at least 3 years in reliability engineering.
• Experience with reliability analysis tools (Weibull, Minitab, JMP, Relia Soft, etc.).
• Familiarity with HALT/HASS methodologies.
• Systems Engineering Simulation and Modeling concepts.
• Systems Engineering methods and procedures.
• Leadership skills in providing guidance to the development team, managing the overall reliability effort, and educating customers.
• Strong root‑cause analysis skills.
• Demonstrated skill preparing documents of high quality for customer submittal.
• Ability to work to program schedule requirements.

• Most locations offer a 9/80 schedule, providing every other Friday off.
• Competitive compensation & 401(k) program to plan for your future.
• Robust medical, dental, vision, and disability coverage with qualified wellness discounts.
• Basic Life Insurance and Additional Life & AD&D Insurances are available.
• Flexible Vacation & PTO.
• Generous Employee Referral Program.
• Voluntary Benefits Available:
  Longer Term Care, Legal, Identity Theft, Pet Insurance, and more.
• Voluntary Tricare Supplement available for military retirees.

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.