Principal Reliability Engineer-Medical Device Development

OVERVIEW:

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.

RESPONSIBILITIES:

Reliability Strategy & Planning


* 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).

Lifetime & Environmental Testing


* 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

Failure Analysis & Root Cause Investigation


* 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.

Design for Reliability (DfR)


* Collaborate with R&D during product development to improve:


* Thermal management


* Mechanical / mechanism stability


* Recommend material and component upgrades to extend lifetime

Data Analysis & Reliability Modeling


* Analyze field and test data using statistical tools.


* Perform Weibull and life data analysis.


* Maintain reliability databases

Customer & Field Service Support


* Support field service teams in diagnosing complex failures.


* Analyze warranty trends and customer feedback.


* Provide technical reports on reliability performance.

QUALIFICATIONS:


* 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 ov...