About the Role

We are looking for an experienced Mechanical Test and Reliability Engineer to join our team. In this role, you will support new product development projects. The role uses engineering, statistics, and durability testing to ensure our implantable cardiovascular medical devices continue GORE's 50 years of medical innovation.

This position will be located at our facility in Flagstaff or Phoenix, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Develop an overall strategy, including durability testing, in support of New Product Development (NPD) Projects to identify and mitigate potential product risk
• Collaborate with NPD Team and other internal teams supporting up to two New Product Development Projects
• Translate anticipated in-vivo use conditions into in-vitro bench top conditions
• Collaborate with Durability Lab Engineers on new test methods and support execution of durability testing
• Develop protocols and reports in support of regulatory submissions
• Drive root cause analysis of test observations
• Provide input and updates to project timeline, risk register, and product design in relation to product durability
• Maintain compliance with training expectations as required for this position
• Perform additional responsibilities as required within the scope of position

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, or Biomedical Engineering
• Minimum 5 years Engineering experience in a regulated environment
• Ability to identify and mitigate risks associated with new product development activities
• Skills include Technical Writing, Project Management, Hands on mechanical, identifying and translating loading modes into benchtop testing and facilitation of problem-solving efforts
• Ability to collaborate with other Reliability Engineers and Technical Associates
• Demonstrated ability to manage multiple priorities, establish realistic deadlines, and drive projects to completion, while keeping stakeholders informed
• Able to provide and receive feedback
• Ability to travel up to 15%

Desired Qualifications

• Experience with Root Cause Analysis (RCA) tools