Job Description
We're seeking a Reliability Engineer to join our team in developing next-generation medical technologies that treat abnormal heart rhythms. Our work saves lives and improves the quality of living for millions worldwide.
* Collaborates closely with Research & Development to develop test methods ensuring they're ready for validation.
* Sure all validations meet required procedures and standards.
* Takes direction from the quality core team member in delivering day-to-day project deliverables as an extended team member.
* Works with engineering and manufacturing functions to establish quality standards.
* Performs reliability analysis on features, requirements, architecture, interfaces, and designs using appropriate techniques (e.g., fault tree analysis, failure trending and analysis) to understand product and process robustness.
* Understands risk management concepts used throughout the quality system to successfully meet FDA and ISO requirements.
* Leverages strategies for test method validations, design verification, and shelf-life protocols/reports.
Requirements
* Demonstrates advanced knowledge combining breadth and depth, typically acquired through education combined with experience.
* Requires a minimum Level 8 Degree in Engineering or relevant discipline and minimum 8 years of relevant experience.
* Or advanced degree with a minimum of 7 years of relevant experience.
* May possess practical knowledge of project management.
* Experience in highly regulated industries, preferably medical devices.
* Able to solve complex issues by interacting with cross-functional groups.
* Proven ability to navigate matrix organizations and complex business systems, regulations, standards, and performance requirements.
* Familiarity with reliability tools and practices supporting requirements, design, integration, and verification/validation.
* Critical thinking skills focused on improved system performance outcomes and positive business impact.
* Excellent communication and influence skills are critical.