Quality Control Inspector II

February 8th, 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:

The primary role of this position is to perform the receiving inspection, in-process inspection, final inspection, test, DHR review and release of the HLT Products and related sub-assemblies and components.  In addition, the QC Inspector will assist in other periodic production and quality tasks in support of production and development processes.

Primary Duties and Responsibilities:

In-process inspection of products and product sub-assemblies or components

  • Dimensional inspection
  • Visual inspection of nitinol wire components and surgical knots in valve subassemblies

Final inspection and release of finished products

  • Visual inspection of finished product
  • Functional testing of products and interpretation of results
  • Review of device history records
  • Final release of product

Incoming / Receiving inspections

  • Inspections of molded/machined or off-the-shelf components using a variety of tools (microscope, ruler, caliper, pin gauge, ring gauge, laser micrometer, borescope, MicroVU, etc.)

Production support and other functions

  • Communicate quality requirements to production staff
  • Assist in general inspection as required and as available
  • Work with engineering to develop or improve inspection and production processes
  • Initiate non-conforming material records when required
  • Assist in product sterilization and packaging

Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • High School degree
  • 2 years of experience in medical device production or inspection or similar experience manufacturing or inspecting small, precision components
  • Strong attention to detail skills, especially in a repetitive manufacturing environment
  • Experience with assembly or inspection
  • Excellent manual dexterity and ability to work under a microscope
  • Experience with medical device production or inspection paperwork
  • Ability to read, understand and follow procedures in English
  • Good interpersonal skills including ability to communicate well with both production personnel and professional staff
  • Ability to work with minimal direct supervision

Preferred:

  • Medical device inspection experience
  • Experience with mechanical or tissue heart valves and/or catheter-based delivery systems
  • Experience using a microscope to perform inspections
  • Experience inspecting catheter tubing using a borescope
  • Experience with using and programming a MicroVu vision system
  • Experience with Grand Avenue Software
  • Cleanroom experience

Work Environment Considerations

  • This job requires approximately 25% cleanroom work – gowning with a bouffant, lab coat, non-latex gloves, and face mask
  • This job requires the use of non-latex gloves for approximately 50% of inspections

For further information about this position, click here http://bit.ly/2Es4FXN