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.
This position will drive/support detailed development of next-generation Transcatheter Aortic Valve Replacement (TAVR) Delivery Systems, subsystems and components from initial concept development through Design Verification & Preclinical Design Validation.
Primary Duties and Responsibilities:
TAVR Delivery System Projects’ Support:
- Develop Delivery System components and subsystems within defined R&D projects.
- Develop in-depth understanding of Delivery System and Valve interface requirements and test methodologies.
- Generate detailed component & subsystem designs, models and drawings using SolidWorks CAD Software; submit drawings for review/approval using HLT’s internal documentation control system.
- Develop effective R&D-stage manufacturing processes to produce prototype designs/parts; work with Manufacturing to transition R&D processes/designs to meet Validation/Qualification requirements.
- Provide inputs to timelines; risk assessments; progress/status of activities. Generate DHF deliverables per project Phase requirements. Support Critical Path
- Management activities
- Develop effective bench test methods; perform/delegate hands-on testing of sub-systems/systems as appropriate.
- Maintain rigorous work documentation during all project phases to support overall project requirements/deliverables and IP/Patent disclosures. Support generation of R&D test protocols & technical reports.
- Analyze test data using statistical tools; perform in-depth interpretation of results and generate detailed technical reports.
- Translate Customer Requirements into effective design concepts/solutions.
- Ensure work and product designs comply with Quality Management System (QMS) and Regulatory (FDA; CE, UL; ISO etc.) requirements.
- Design products to meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by management.
- Participate in Preclinical study planning & execution.
- Support device development activities from concept to commercial launch.
- Interface directly with other functional groups – predominantly Quality and Manufacturing.
- Provide work direction to R&D technicians.
- Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes.
- Identify and promote/coordinate the acquisition of needed R&D equipment & supplies.
- Pursue continuing education and training consistent with company objectives.
Qualifications (Knowledge, Skills & Abilities):
- Bachelor of Science Degree in Engineering (Mechanical or Biomechanical).
- Minimum of 5 years medical device product development experience.
- Demonstrated proficiency with SolidWorks CAD modeling and engineering drawing generation./li>
- Hands-on experience developing/subcontracting “soft” rapid prototypes for initial engineering testing and screening.
- Demonstrated working knowledge of medical device delivery system technologies/processes including delivery catheter design and fabrication methods; guidewires; micro-machining; laser welding; single/multi lumen extrusions; polymers, metals, coatings; corrosion; adhesive bonding; sterilization processes; shelf life considerations.
- Fluent with Phase-driven Class III medical device product development cycles, requirements and deliverables.
- Demonstrated ability to develop product-driven bench test methods & to perform hands-on testing and test results interpretation.
- Strong interpersonal, communication, and technical writing skills.
- Experience with directing the work of technicians.
- Hands-on experience with Preclinical (animal studies) testing & analysis.
- Strong working knowledge of human & animal physiologies; particularly cardiology
- Direct experience designing TAVR heart valve or other Class III implantable device delivery systems.
- Lead engineer experience for a complex Class III implantable device/system.
- 2+ years of experience managing or leading the work of technicians.
- Working knowledge of Cath Lab procedures & requirements.