Test Engineer III

1 month ago


Danvers, United States Mondo Full time

Title: Test Engineer III

Location: Onsite in Danvers, MA

Duration: 12+ months with opportunity for hire after 6; includes benefits

Start Date: ASAP

Rate: Competitive and dependent upon experience


Unfortunately, we cannot work with third party employers or those on STEM visas at this time.


As a Test Engineer, you will drive technical efforts, support design initiatives by providing clinically relevant tests, computational models, and engineering activities for cutting-edge intelligent cardiac pump systems, both for acute treatment as well as long term support systems. You’ll have a tangible impact on our business and be rewarded by a positive impact to patients' lives.


Principle Duties and Responsibilities:

  • Participate in project team development activities; provide ideas and concepts to help drive development efforts –include designing and executing exploratory tests to hone in on the best design option.
  • Lead Test Method Validation for a variety of electromechanical needs.
  • Develop test benches and fixturing to simulate use and in-vivo conditioning of the product.
  • Develop clinically relevant experimental testing that reproduce failure modes observed with product use.
  • Coordinate with project leaders and conduct technical design reviews to drive project to a conclusion.
  • Design and execute tests to verify products against requirements.
  • Perform data/statistical analysis to support test conclusions.
  • Design and author and execute test plans/protocols and test reports.
  • Own closure of the Design Trace Matrix, working closely with Engineering and Quality to prepare a complete Verification and Validation package.
  • Participate in guidance document and standards creation processes with FDA/industry/academia
  • Contribute to test methodology development and best practices.
  • Conduct or supervise standard tests as required.


Job Qualifications:

  • 3-5+ year product development or test engineering experience or relevant Master’s/co-ops
  • BS required in engineering or science discipline, Master’s a plus
  • V&V experience in medical devices
  • Experience and ability interacting with FDA and other regulatory agencies.
  • Knowledge in medical device clinical use, design controls and regulating standards
  • Hands on with developing and using test equipment.
  • Passionate about knowing how and why things fail.
  • Passionate about improving the performance of existing products.
  • Ability to write clear and understandable technical articles
  • Knowledge of cath lab and/or cardiothoracic/vascular surgical environments is a plus

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