May 17th, 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.
Manage and lead Tissue Valve Assembly manufacturing group. Responsible for documenting, implementing, and improving the manufacturing processes, specifically Valve Assembly manufacturing. 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. Identify, construct and implement improvements to process or design. Provide required and necessary training to production operators and other manufacturing personnel.
Primary Duties and Responsibilities:
Projects – Process and Product Development
- Plans, directs, and coordinates manufacturing process development activities around design or processes for medical device assembly
- Provides management of projects chartered to improving manufacturing methods or design
- Familiar with statistical methods and terminology
- Leads a team concerning product design and selection of tooling, vendors, materials, etc. to ensure efficient production methods are selected and the product meets the requirements
- Expert representative on a project, product, and/or process development activity who brings forth the utilization of GMP and design for manufacturing methodologies to assure and improve efficiencies and product designs
- Supports the manufacturing operation 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
- Serves as project manager for sub-categories of larger initiatives or program
- Supervises manufacturing personnel to assure initiatives are met in accordance to broader scope:
- Incoming product acceptance and quality
- In process acceptance and quality
- NCMR and quality monitoring of components and output
- Calibration and Preventative maintenance of production tools, fixtures, gauges, and equipment
Technical Documentation and Training
- Drafts models and writes documentation to define a product or process fully for use in a regulated environment
- Writes clear and detailed test protocols and reports
- Provides expert reference to technical resources (technicians, engineers and assemblers) to assure drawings, work instructions, methods are fully defined and validated and able to be effectively conveyed to the production staff
Qualifications (Knowledge, Skills & Abilities):
- BS in an engineering discipline
- 5+ years’ experience as a manufacturing engineer in a regulated environment
- 3+ years’ manufacturing manager experience
- Effective oral and written communication skills
- Demonstrated organizational and administrative skills
- Ability to prioritize and handle multiple tasks
- Demonstrated problem-solving skills
- Ability to interpret, follow and promote the quality policy of the org as an operating guideline
- BS in Manufacturing Engineering
- 5 yrs experience as a manufacturing manager in medical device environment
- Demonstrated expertise in a variety of process technologies and manufacturing environments
- Demonstrated leadership experience or operated in a leadership capacity (e.g.; production lead, problem solving) in a manufacturing environment for minimum 2 years
- Demonstrated ability to perform job duties of all subordinate positions
Travel requirements are limited. Total travel expected to be less than 10%.
For further information about the position, please click here https://bit.ly/2wIONxv