Principal R&D Engineer – Product Reliability and Compliance
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.
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. Our current need is for an engineer to join our team. If you are the right person, you have existing knowledge/training to bring reliability test method development expertise into our 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 TAVR market with the most exciting product out there we are looking forward to meeting you.
Primary Duties and Responsibilities
Product Reliability and Compliance
- 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
Qualifications (Knowledge, Skills & Abilities)
- Bachelor of Science in an Engineering discipline
- 10+ 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
- 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
Travel requirements are limited. Total travel expected to be less than 10%.
For further information about the position, please click here https://bit.ly/2IL6Nd3