Sr. Delivery System Specialist

July 19th, 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 function of this position is to support the Delivery System manufacturing operations and development.  The Sr. Delivery System Specialist will perform activities associated with the manufacturing of medical devices such as hand assembly, molding and forming operations, cleaning, and inspection.  In addition, the Sr. Delivery System Specialist will be responsible for maintaining processes and procedures, equipment, and assisting in validation and verification activities. The Sr. Delivery System Specialist will possess the ability to adjust and adapt from development to manufacturing while maintaining the integrity of the Delivery System manufacturing area and the organization.

 

Primary Duties and Responsibilities:

  • Supports the manufacturing operation to ensure continuous and uninterrupted flow of product to maintain production output per established schedules
  • Supports Engineers in the implementation and deployment of product and process improvements and design transfer activities, including training of catheter assembly staff
  • Uses established standard operating procedures (SOP’s) and manufacturing procedures (MPs) to carry out the non-conforming material report (NCMR) process for physical dispositions, along with appropriate reporting and documentation
  • Identify and communicate possible changes for improvement to manufacturing procedures (MP’s) to Manufacturing Engineer
  • Identify tooling and fixture needs and communicate them directly to the manufacturing engineer
  • Identifies inventory and production order needs by utilizing both the Enterprise Resource Planning (ERP) system and physical product levels in the warehouse
  • Tests assemblies when indicated on MP’s
  • Perform assembly design verifications, validations, test builds, prototypes etc. per instructions
  • Sets up and maintains production floor materials and equipment, e.g.; assembly equipment, tooling, test equipment, etc.
  • Perform training of Delivery System assembly staff
  • Sets up and maintains cleaning floor materials and equipment, e.g.; cleaning tanks and clean bench etc.
  • Perform training of parts cleaning to staff
  • Performs in-process inspection of product
  • Performs hands-on activities such as product assembly, molding, bonding. Measuring, trimming and product testing to support the production schedule during times of transition and increased demand or change implementation
  • Aids in the coordination of tooling and equipment essential for production and inspection processes
  • Support Engineers and Technicians with the implementation and deployment of product and process improvements and design transfer activities, including basic training and answering of questions from staff

Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • Ability to read and understand English
  • 2-Year technical degree or high school diploma and 5-7 years manufacturing technical experience.
  • Excellent recordkeeping and organizational skill
  • Excellent communication/written skills
  • Intermediate computer skills
  • Ability to perform arithmetic calculations including converting units of measure
  • Ability to work with small components and hand tools under a microscope
  • Ability to follow detailed written and verbal instruction
  • Work in a Clean Room environment involving personal use of gowns/gloves/masks while performing activities
  • Ability to produce high quality workmanship with attention to detail
  • Ability to multitask
  • Perform manufacturing and assembly of the Delivery System in accordance to current good manufacturing practices
  • Good laboratory practices and documentation practices
  • Provide support to other manufacturing operations or departments, as needed
  • Assist in training of production assemblers

Physical Requirements:

  • Ability to lift 20 lbs.
  • Hand/eye dexterity
  • Ability to work safely in an environment that involves the risk of being exposed to hazardous chemicals, high pressure equipment, and biological materials and organisms

For further information about the position, please click here https://bit.ly/2L1ABq6