R&D Manager of 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 a leader 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 by leading a team of test engineers. 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 Reliability and Compliance
- Planning and leading product safety and reliability technical assessments and compliance activities to ensure that reliability and safety is designed into products
- Developing testing methodology that enables the design team to demonstrate product reliability
- Management and execution of all valve performance testing per ISO 5840, such as hydrodynamic testing, accelerated wear test, durability, flow visualization, steady flow testing, etc.
- Developing protocols, procedures, test method validations, test fixtures and reports
- Develop anatomical test models for product testing and/or training and their rationale for clinical relevance
- Develop test plans for demonstrating compliance to regulatory standards, both US and outside US
- Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs
- Develop computational modeling strategies (Finite Element Analysis, Flow Visualization, etc) that enable rapid product development and rapid learning
- Manage a team of computational modeling experts, including outside vendors
- Promote data driven testing methodology
- Manage team of engineers and technicians to ensure completion of projects on time and within budget, including personnel allocation and prioritization
- Conduct performance reviews, scheduling of resources and establishing goals and objectives for team members
- Develop staff capabilities by upgrading employee skills and fostering a work environment that encourages team work, rewards results, and delivers speed-to-market solutions
- Mentor and develop personnel; provide continuous performance feedback, and conduct all required performance planning, assessment and review activities
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
- 5+ years of people leadership experience
- 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 catheter-based implantable devices
- Experience with Class III implantable device development, specifically prosthetic heart valves
- Experience managing/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/2RD1TCS