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R & D Manager

Employer
HLT, Inc
Location
Hamel
Salary
Competitive

View more

Industry
Healthcare
Role
Manager
Job Type
Long-Term
Hours
Full Time

HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We are committed to advancing TAVR therapies to improve lives. 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 75+ 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 3,500 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:

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 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 R&D Manager to join our team.


This manager will ensure the Valve R&D team is focused and executing on the right things to move the business forward. This person must have a driven, motivational personality and an infectious sense of optimistic collaboration. Accountability, ambition, and the willingness to wade into detailed problem solving are a must to succeed in this role. This individual will be responsible for the valve team execution of key technical aspects of the valve development process, supervising the work of engineers and technicians to ensure alignment within the project team. This manager be very engaged with the technical and cross-functional staff, translating broad technical objectives into discrete timelines and prioritize deliverables, development activities, and engineering evaluations to ensure steady progress towards company objectives is had.


This manager must be comfortable and competent in identifying product and project risks, analyzing complex multivariate systems and small-sample-size data sets, and leading others to accomplish a technical project goal that will satisfy strict regulatory requirements. Wearing multiple hats is a feature of this job; this individual will be constantly be managing different aspects of multiple projects along the product development pathway and be responsible for ensuring deliverables are cross-functionally reviewed and approved. This is a functional manger role that will also be integrated into the development process, assisting the team with protocol and report writing, data/results review, analytical analysis, testing and acquiring data, and presenting results and conclusions.


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? Then we are looking forward to meeting you!


Primary Duties and Responsibilities:

Valve R&D Team Leadership:

  • Manage an inventive staff of engineers and technicians, providing work direction and mentorship.
  • Use well-practiced leadership and communication skills to facilitate cross-functional discussions and to solve department-spanning problems.
  • Implement best practices of medical device development, including data generation and analysis, ideation, prototyping, documentation, and testing.
  • Drive a mindset within the valve R&D staff to enable data-driven risk taking and create a lean, fast-moving mentality around quality-driven design activity.
  • Lead by example, exemplifying discipline within the product development process and maintaining a steady focus on delivering quality-focused design process output.
  • Focus on implementing data-driven testing methodologies to lead valve design performance improvement efforts.
  • Conduct design reviews, with input from a cross-functional team, to present and statistically analyze test data and valve designs.
  • Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
  • Represent Valve R&D on cross functional teams to develop functional improvements to both device design, manufacturing, and quality control processes.

Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • Bachelor of Science Degree in Engineering or equivalent/related experience
  • Decisive and collaborative approach with a demonstrated drive for success and progress towards company goals
  • 6+ years of research and development engineering experience (or related experience)
  • Experience owning PDP deliverables within an R&D department
  • 1 year of managing a small team of design engineers and technicians
  • Working knowledge of class III implantable medical devices
  • Ability to lead and manage the work of engineers and technicians
  • Adept in design of experiments and statistical analysis (Minitab preferred)
  • 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

Preferred:

  • Master's Degree / advanced training in Engineering Management and/or Technical Leadership
  • 3+ years of direct management of 5+ engineers / technicians
  • Previous work experience in the structural heart product segment

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