Research and Development Engineer II
January 7th, 2019
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.
The R&D Engineer II provides ongoing support to the HLT Valve group. This engineer will primarily be responsible for development and implementation of valve assembly designs, valve materials, assembly fixtures/aids and the evaluation valve functionality. Responsibilities will also include root cause analysis for current designs. The candidate should have strong experience in design controls and preparing materials for product submission on Class II or Class III devices. The R&D Engineer II provides ongoing support to the HLT Valve group.
Primary Duties and Responsibilities
Valve Assembly Design Lead:
- Grow institutional knowledge base and understanding of functional valve requirements through exploratory testing and industry research
- Investigate design concepts and assess impact on function, delivery system interaction and manufacturability
- Provide clear direction to technicians and production operators to actualize design concepts
- Build devices alongside operators to evaluate design for manufacturability
- Design and coordinate fabrication test fixtures and test methods
- Generate design documentation including design specifications, manufacturing processes, test protocols/reports
- Communicate status of activities, key learnings and make recommendations to core project team members
- Investigate sources of valve process variability and provide process improvements
Quality Compliance and Regulated Practices:
- Understand the basics of design controls and generate deliverables for each phase of the project including design inputs, design outputs, risk analysis, design verification and design transfer
- Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
- Commit to fostering and driving an environment and work output based on continuous improvement
Qualifications (Knowledge, Skills & Abilities):
- Bachelor of Science Degree in Engineering (Mechanical or Biomedical)
- 2-5 years of research and development engineering experience
- Experienced in product development
- Experienced in equipment and fixture design
Skills and Abilities:
- 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
For further information about the position, please click here https://bit.ly/2C3x5Ek