Mechanical Reliability and Test Development Engineer

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

W. L. Gore & Associates, Inc. in Phoenix, AZ seeks an experienced Mechanical Reliability and Test Development Engineer to advance durability strategies for implantable cardiovascular devices.

The role blends engineering judgment, statistics, and bench testing to support new product development while ensuring compliance with regulatory expectations and Gore’s medical innovation standards. Hybrid work is possible and travel up to 15% is anticipated.

Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Science, or Biomedical Engineering.
• Minimum 10 years engineering experience in a regulated environment.
• Hands-on mechanical testing experience and investigation of observations.
• Strong communication and ability to drive projects to completion with stakeholders.

Responsibilities

• Develop durability evaluation strategy with testing and rationales for product development.
• Collaborate with product development teams and internal groups on multiple projects.
• Translate anticipated in vivo use conditions to in vitro bench top conditions.
• Develop or review protocols and reports for regulatory submissions.
• Lead root cause analysis of test observations and drive corrective actions.
• Update project timelines, risks, and product design related to durability.
• Maintain training compliance and continuously improve durability techniques.

Skills

Engineering experience

Hands-on testing

Project collaboration

Education

Bachelor's degree in Mechanical Engineering, Materials Science, or Biomedical Engineering

Job description

About the Role

We are looking for an experienced Mechanical Reliability and Test Development 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 Phoenix, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Develop an overall durability evaluation strategy, including durability testing and rationales, supporting product development projects to identify and mitigate potential product risk
• Collaborate with product development teams and other internal teams supporting multiple projects
• Translate anticipated in vivo use conditions into in vitro bench top conditions
• Collaborate with durability test engineers on new test methods and support the execution of durability testing
• Develop or review protocols and reports in support of regulatory submissions
• Drive root cause analysis of test observations
• Provide input and updates to project timeline, risk, and product design in relation to product durability
• Maintain compliance with training expectations as required for this position
• Continuous improvement of product development durability techniques and processes

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Science, or Biomedical Engineering
• Minimum 10 years Engineering experience in a regulated environment
• Experience with hands on mechanical testing and investigating testing observations
• Demonstrated initiative, self-motivation, and self-direction, with the ability to collaborate effectively with engineers and technical Associates
• Demonstrated ability to manage multiple priorities, establish realistic deadlines, and drive projects to completion, while keeping stakeholders informed
• Ability to break down complex problems into actionable steps
• Ability to identify and mitigate product and business risks associated with product development
• Ability to translate anticipated use conditions into bench top conditions
• Strong technical writing skills and experience executing the documentation review process
• Ability to travel up to 15%

Desired Qualifications

• Experience utilizing the scientific method
• Experience with fatigue, wear, and/or creep testing and evaluation
• Experience with medical device product evaluation

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

What We Offer

• We provide benefits that offer choice and flexibility and promote overall well-being.
• And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing".
• Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace.

All employment is contingent upon successful completion of drug and background screening.

Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States.

Gore generally will not sponsor visas unless otherwise noted on the position description.