Manager, Tissue and Sterilization

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:

Manage and lead Tissue Processing and Sterilization group. 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 of valve and delivery system products.  This includes creating plans for routine monitoring of sterility for clinical devices.  Responsible for documenting, implementing, and improving the Tissue and Sterilization processes. Manage and lead process development and process verification/ validation activities.  Manage cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources.  Provide required and necessary training to production operators and other manufacturing personnel.

Primary Duties and Responsibilities:

Process Development

  • Plans, directs, and coordinates Tissue and Sterilization process development activities around design or processes for medical device assembly
  • Provides management of projects to improve manufacturing methods
  • Reviews data and develops trending models to determine if corrective and/or preventive actions are required
  • Leads a team concerning process design and selection of tooling, vendors, materials, etc. to ensure efficient production methods are selected and the product meets the requirements
  • Maintain familiarity with current standards and requirements related to tissue use and testing requirements for both EU and US

Production Management

  • Supports the manufacturing operation daily to ensure production of product
  • Troubleshoots design or process issues, implements improvements, and supports all other daily activities such as NCMR (non-conforming material review), re-work, and implementation of change orders
  • Analyzes processes and creates methods for process and quality monitoring including development of and reporting of metrics
  • Manages relationships with current Tissue and Sterilization suppliers.  Responsible for supplier evaluation
  • Leads effort in developing criteria for selection of alternative Tissue and Sterilization suppliers
  • Supervises manufacturing personnel to assure initiatives are met in accordance to broader scope:
  1. Incoming product acceptance and quality
  2. In process acceptance and quality
  3. NCMR and quality monitoring of components and output
  4. Calibration and Preventative maintenance of production tools, fixtures, gauges, and equipment

Qualifications (Knowledge, Skills & Abilities):

Minimum

  • BA/BS in Engineering or Science related field
  • 3+ years of related tissue and/or sterilization experience
  • Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Adept in design of experiments and statistical analysis
  • Experienced in process development, material characterization, materials testing systems
  • Knowledge of collagenous tissues:  structure, biology, mechanics
  • Working knowledge of biological assays
  • 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 support personnel

Preferred

  • Bachelor of Science Degree in Microbiology or another related field
  • Knowledge and experience with standards such as ISO 5840 Cardiovascular Implants and ISO 22442 Medical Devices utilizing Animal Tissue
  • Previous experience managing tissue and sterilization processes (liquid chemical and EO)

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/2LpZKKr