Reliability Engineering Role
The Principal Reliability Engineer will work closely with the Research & Development team in developing Test methods to ensure they are ready for the Test Method Validation (TMV) process.
This position involves ensuring all TMVs are validated to meet the required TMV procedure and standards. Collaborating with engineering and manufacturing functions to guarantee quality standards are in place.
The role requires systematic reliability analysis against features, requirements, architecture, interfaces, and designs through the appropriate application of reliability engineering techniques.
You will lead strategies for test method validations, design verification and shelf-life protocols/reports.
Risk management concepts used throughout the quality system are essential to successfully meet regulatory requirements.
Key Responsibilities:
* Developing and implementing Test methods for TMV processes
* Collaborating with engineering and manufacturing functions to guarantee quality standards
* Leading strategies for test method validations, design verification and shelf-life protocols/reports
* Ensuring all TMVs are validated to meet the required TMV procedure and standards
Requirements:
* Advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience
* 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 a highly regulated industry preferably medical devices is essential
* Proven ability to operate in a matrix organization and navigate complex business systems regulations standards and performance requirements
* Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
* Excellent communication and ability to influence