Senior Reliability Systems Engineer
About the Role
As a Senior Reliability Systems Engineer, you will spearhead the validation of high-stakes electromechanical systems, ensuring that our next-generation medical technology meets the highest standards of performance and safety. You will bridge the gap between design and production by implementing rigorous testing frameworks that guarantee product longevity and reliability in critical environments.
Responsibilities
Design and implement comprehensive reliability test strategies, including Accelerated Life Testing (ALT) and HALT/HASS, to validate complex electromechanical assemblies.
Develop and maintain automated testing infrastructure using Python and C++ to streamline verification cycles and enhance data accuracy.
Translate product requirements into actionable reliability growth plans and technical verification protocols for new product introductions.
Utilize advanced statistical methodologies, such as Weibull analysis and Fault Tree Analysis, to drive evidence-based design improvements.
Collaborate with cross-functional R&D and manufacturing teams to integrate risk management into the product lifecycle.
Analyze field performance data and failure trends to proactively mitigate risks and improve system robustness.
Author detailed technical reports and documentation to ensure full compliance with regulatory standards.
Required Skills
Bachelor’s or Master’s degree in Electrical, Mechanical, or Biomedical Engineering.
5+ years of experience in reliability engineering within highly regulated sectors like medical devices.
Expertise in ISO 13485 and FDA 21 CFR 820 regulatory frameworks.
Proficiency in reliability prediction modeling using standards such as MIL-HDBK-217 or Telcordia.
Strong statistical analysis skills and the ability to influence technical stakeholders.
Preferred Skills
ASQ Certified Reliability Engineer (CRE) or Certified Quality Engineer (CQE) designation.
Hands-on experience with machine tools and manufacturing processes.
Proven track record in mentoring junior engineers on reliability best practices.