Senior R&D Scientist/Engineer

July 24th, 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:

This position will support the R&D team and cross functional team by conducting activities critical to valve development and testing. The primary responsibility will be developing the tissue component of the valve. This position is responsible for understanding and improving all aspects of preparing tissue for assembly into a valve, from sourcing raw material to final selection and quality control criteria. In addition, this position is responsible for ensuring overall sterility and biocompatibility of valve and delivery system designs. This includes managing initial biocompatibility testing and sterilization validations for new products as well as helping to create plans for ongoing assurance of sterility and biocompatibility for clinical product.

Primary Duties and Responsibilities:

Valve Tissue Material Development and Investigations

  • Research and implement new and revised tissue preparation and fixation methods to enhance long term implant performance including anti-mineralization characteristics
  • Develop program to study relationships between tissue material and structural properties and product performance
  • Supervise investigational studies relating material selection and processing to implant functionality
  • Propose and implement improvements for sorting and qualifying tissue used in manufacturing valve replacements
  • Generate specifications and supporting data to be transferred to manufacturing
  • Represent Research and Development on cross functional teams to develop functional improvements to both device design, manufacturing, and quality control processes
  • Grow institutional knowledge base and understanding of tissue mechanics and processing through exploratory testing and industry research
  • Prepare technical reports which summarize data and provide the team with insightful analysis of results from experimentation
  • Communicate status of activities, key learning’s and make any recommendations to project team members and other functional departments
  • Maintain familiarity with current standards and requirements related to tissue use and testing requirements for both EU and US

Sterility and Biocompatibility

  • Ownership of sterilization validation and biocompatibility assurance for new products and materials
  • Manage sterilization validations and biocompatibility assessment for both the valve and delivery system
  • Assess impact on sterilization validations and biocompatibility of material, design, and process changes

Design Transfer

  • Work with operations to manage the sourcing and qualification of tissue vendor
  • Generate specifications and supporting data to be transferred to manufacturing and quality
  • Direct transfer of tissue related process improvements and design changes to manufacturing

Quality, Compliance, and Regulated Practices

  • Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
  • Provide equipment and test method validation to meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by management
  • Committed to fostering and driving an environment and work output based on continuous improvement

Qualifications (Knowledge, Skills & Abilities):

Minimum

  • Bachelor of Science Degree in Engineering (Mechanical, Materials or Biomedical) or related field
  • 5 years of R&D experience or advanced degree (MS or Ph.D.) in Engineering (Mechanical, Materials, or Biomedical) and 3+ years of experience
  • Adept in design of experiments and statistical analysis
  • Experienced in test method development, material characterization, materials testing systems
  • Adept in equipment and fixture design
  • Knowledge of collagenous tissues: structure, biology, mechanics
  • Working knowledge of biological assays (histology, protein content, structural quantification)
  • Self-starter with a demonstrated ability to remain productive with minimal supervision
  • Ability to coordinate and execute multiple projects simultaneously
  • Strong interpersonal, communication, and technical writing skills.
  • Ability to give work direction to technician support personnel

Preferred

  • Master of Science Degree in Engineering (Mechanical or Biomedical) or related field
  • 5+ years of medical device R&D experience
  • Working knowledge of SolidWorks
  • Previous work experience in the structural heart product segment
  • Experience with other materials such as polyesters, and/or Nitinol
  • Experience in heart valve design and testing
  • Previous experience with sterilization validations and biocompatibility studies

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/2LxGjiY