MedTech Durability & 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

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.