Job Title:
Senior Reliability Specialist
* Collaborates with the R&D team in developing test methods for validating products against required standards.
* Ensures all product validations meet established procedures and quality standards.
* Works closely with the quality core team to deliver project outcomes as an extended member.
* Collaborates with engineering and manufacturing teams to maintain quality control processes.
* Performs systematic reliability analysis on features, requirements, architecture, interfaces, and designs using techniques such as fault tree analysis, failure trending, and reliability forecasting.
* Applies risk management principles to ensure compliance with FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
* Develops strategies for test method validation, design verification, and shelf-life protocols/reports.
Requirements:
* Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
* Requires a minimum Level 8 Degree in Engineering or other relevant discipline and minimum 8 years of relevant experience.
* Or advanced Degree with a minimum of 7 years of relevant experience.
* May have practical knowledge of project management.
* Experience in a highly regulated industry, preferably medical devices.
* Experience with solving complex issues by interacting with cross-functional groups.
* Proven 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.
* Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
* Excellent communication and influencing abilities are essential for this role.