Job Title: Principal Reliability Engineer
Key Responsibilities:
* Collaborate with R&D to develop and validate test methods for the Test Method Validation (TMV) process.
* Ensure TMVs are validated against required procedures and standards.
* Deliver day-to-day project deliverables as an extended team member under the quality core team's guidance.
* Work with engineering and manufacturing functions to establish quality standards.
* Perform systematic reliability analysis of features, requirements, architecture, interfaces, and designs using various techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting) to assess product and process robustness.
* Apply risk management concepts throughout the quality system to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
* Lead strategies for test method validations, design verification, and shelf-life protocols/reports.
Requirements:
* Requires advanced knowledge in job area combining breadth and depth, typically obtained through advanced education combined with experience.
* Must have a minimum Level 8 Degree in Engineering or relevant discipline and at least 8 years of relevant experience.
* Alternatively, advanced degree with at least 7 years of relevant experience.
* May possess practical knowledge of project management.
* Experience in highly regulated industry, preferably medical devices.
* Proven ability to solve complex issues by interacting with cross-functional groups.
* Ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.
* Knowledge of reliability tools and practices that effectively support requirements, design, integration, and verification, and validation.
* Critical thinking skills with focus on improved system performance outcomes and positive business impact.
* Excellent communication and influence skills essential for the role.