Senior R&D Engineer – Heart Valve Frame Design

October 9th, 2018


HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We manufacture a transcatheter heart valve system, consisting of a catheter-based delivery system and heart valve, to treat aortic valve disease.  The procedure is performed by an interventional cardiologist / cardiac surgeon in a cardiac catheterization laboratory, and is expected to be both less invasive and less costly than an open heart valve replacement procedure.  The company currently employs approximately 100 people in Maple Grove, Minnesota.

In 2010 HLT was acquired by The Bracco Group, an international company active in the healthcare sector through Bracco Imaging. The group employs more than 3,300 employees worldwide and has annual total consolidated revenues of more than $1 billion.

HLT seeks passionate and talented people who can start contributing from day one. We want innovators seeking to advance the state of the art to improve patient outcomes.

Position Summary

We are a fast paced, fail fast R&D organization that is dedicated to providing the best TAVR solution to the market. Our technology is a unique Nitinol based design and it is addressing major unmet needs in the market. As a result, we are looking for high impact, self-starter, agile individuals who value creativity, learning and data above all else. One of our current needs is for a driven R&D engineer. If you are the right person you have existing knowledge/training to bring metals development expertise into our team. You are looking forward to empowering us with rapid data generation on design options as well as developing test methods to qualify products before release. You are excited about utilizing novel computational modeling techniques to generate data and enable iteration of designs faster than any other organization.

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

Primary Duties and Responsibilities

Product Design

  • Create new braided nitinol structures / frame designs to support next generation transcatheter aortic heart valves
  • Design and implementation of numerous new transcatheter heart valve design concepts that meet user requirements
  • Develop nitinol property specifications
  • Technical contributor to project team, generating new device concepts and product specifications
  • Narrow concept design selections using data driven decision making methodology
  • Conduct cross-functional design reviews

Process Development

  • Designs implants for manufacturability
  • Prototype transcatheter heart valve concepts
  • Develop nitinol processing parameters to achieve desired mechanical performance
  • Develops manufacturing processes and related tooling/CAD drawings
  • Develop critical in-process specifications/inspections

Product Characterization

  • Creates, validates and executes test methods to support design characterization for product development and regulatory submissions
  • Familiarity with appropriate regulatory guidance documents (ISO 5840) and industry standards
  • Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis

Qualifications (Knowledge, Skills & Abilities)

Minimum:

  • Bachelor of Science in an Engineering discipline
  • 5+ years of experience in the medical device field with product development
  • Characterization and materials development focused on nitinol / metals
  • Excellent verbal and written communication skills
  • Strong interpersonal skills
  • Demonstrated problem solving and decision-making skills
  • Statistical data analysis experience utilizing Minitab software

Preferred:

  • Experience with prosthetic heart valves
  • Masters or PhD in metals, specifically nitinol
  • Experience with catheter-based implantable devices
  • Experience managing R&D Technicians

Other

Travel requirements are limited.  Total travel expected to be less than 10%.

For further information about the position, please click here https://bit.ly/2A0vcIK