Job Summary
We are seeking an experienced Principal Reliability Engineer to join our team. In this role, you will be responsible for ensuring the quality and reliability of our products.
The successful candidate will have a strong background in engineering and a minimum of 8 years of experience in a similar role. A Level 8 degree in Engineering or a relevant discipline is also required.
Main Responsibilities:
* Develop and implement test methods to ensure product readiness for validation.
* Validate all Test Method Validations to meet required procedures and standards.
* Collaborate with research and development teams to deliver project deliverables.
* Work closely with engineering and manufacturing functions to ensure quality standards are met.
* Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs.
* Apply risk management concepts to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
Key Requirements:
* Advanced knowledge of job area combining breadth and depth.
* 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.
* Practical knowledge of project management.
* Experience in highly regulated industries, preferably medical devices.
* Ability to operate in matrix organizations and navigate complex business systems, regulations, standards, and performance requirements.
* Knowledge of reliability tools and practices that support requirements, design, integration, verification, and validation.
* Critical thinking skills with focus on improved system performance outcomes and positive business impact.
* Excellent communication and ability to influence.