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Principal/Manager R&D Engineer

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Location
MN
Job Type
Direct Hire
Date
Oct 24, 2018
Job ID
2635211
Our client, a small clinical trial stage company was acquired by an international billion dollar medical device company. They are a fast paced, fail fast R&D organization that is dedicated to providing the best solution to the market. Their technology is a unique Nitinol based design and it is addressing major unmet needs in the market. As a result, they are looking for high impact, self-starter, agile individuals who value creativity, learning and data above all else. Their current need is for an engineer to join the team. If you are the right person, you have existing knowledge/training to bring reliability test method development expertise into the team. You are looking forward to empowering us with rapid data generation on design options as well as identifying test strategies to qualify products before release.

If you are looking forward to making a big contribution to a dedicated team of fast moving R&D professionals in this massive market with the most exciting product out there we are looking forward to meeting you.

Your role with the company:

  • Develop methods to test valve and valve components in accordance to applicable standards and regulations, particularly in the areas of hydrodynamic performance, valve durability and fatigue
  • Design and oversee fabrication of test equipment and tooling
  • Propose and coordinate the purchase, installation and qualification (IQ, OQ and PQ) of capital equipment
  • Perform valve related testing such as fatigue, durability, hydrodynamic, tensile and deployment testing
  • Write Protocols and Reports that can be used to support regulatory submissions
  • Establish calibration and maintenance procedures for test equipment
  • Develop anatomical test models for product testing and/or training and their rationale for clinical relevance
  • Utilize data driven testing methodology to contribute to improved valve design
  • Conduct design reviews, with input from a cross-functional team, to present and statistically analyze test data
  • Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation

Desired Profile:

  • Bachelor of Science in an Engineering discipline10+ years of experience in the medical device field with product development, testing, test lab management
  • Excellent verbal and written communication skills
  • Strong collaborative interpersonal skills
  • Demonstrated problem solving and decision-making skills
  • Proficient in statistical analysis
  • Ability to work in a fast-paced environment
  • Travel up to 10%

PREFERRED:

  • Masters or PhD in an Engineering discipline
  • Experience with heart valve testing equipment, specifically BDC Labs Durability and Hydrodynamic testers
  • Experience with engineering software: SolidWorks, Matlab, Minitab, etc
  • Experience with catheter-based implantable devices
  • Experience with Class III implantable device development, specifically prosthetic heart valves
  • Experience supervising a staff of engineers/technicians