Principal Reliability Engineer-Medical Device Development

HiArc•Merrimack, NH

About The Position

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

Requirements

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 a least 3 years in reliability engineering
Experience with reliability analysis tools (Weibull, Minitab, JMP, ReliaSoft, 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, managing the overall reliability effort and customer education and progress
Strong root cause analysis skills
Demonstrated skill preparing documents of high quality for customer submittal
Ability to work to program schedule requirements

Responsibilities

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), 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 mechanized mechanical assemblies.
Establish degradation monitoring protocols
Lead root cause analysis on development & production instrument / module failures.
Apply structured methodologies (FMEA, 8D, Fishbone, Weibull analysis).
Work with suppliers to address component-level reliability issues.
Collaborate with R&D during product development to improve: Thermal management, Mechanical / mechanism stability
Recommend material and component upgrades to extend lifetime
Analyze field and test data using statistical tools.
Perform Weibull and life data analysis.
Maintain reliability databases
Support field service teams in diagnosing complex failures.
Analyze warranty trends and customer feedback.
Provide technical reports on reliability performance.