Position Summary
The Production Manager will support Manufacturing and Quality Compliance efforts throughout
Provide support overseeing the manufacturing operations team and supporting cross functional teams
focused on sustaining and implementing continuous improvements.
The Production Manager primary function is to provide day to day support of the catheter
manufacturing floor operations. This position will support investigations tied to non-conforming
product as well as processing general Non-Conformance (NC) tasks. In addition, the Production
Manager is responsible for contributing to continuous improvement projects focused on the
manufacturing line to reduce costs, while maintaining quality compliance, using the application of lean
problem-solving tools. Accountable for deliverables in good documentation practice, the design
control process, and other required methods of documentation.
Principal Responsibilities
 Manage a team of manufacturing engineers, all production personnel overseeing three shifts
and all maintenance team.
 Support investigations tied to Non-Conformances, Complaints, and CAPA. Produce as team
member of investigative team as required for leadership or engineering technical assistance.
 Support manufacturing actions identified through production visual management boards
 Support large and small projects targeted at reducing waste, increasing productivity, and
reducing stress on the operations and its operators. Demonstrate learning and basic
understanding in the use of the tools of improvement – Six Sigma and Lean Tools.
 Keep track of industrial trends in applications and technologies, including practices and
engineering tools. Maintain knowledge of technology changes to be able to implement at
Natec.
 Support R&D activities as required utilizing technical skills to provide positive input to projects
and to manage the transfer process from design to manufacturing. Ensure new platforms are
capable of manufacturing in a cost-efficient manner.
 Demonstrate basic project management skills including but not limited to defining scope,
identifying measurable results, methods and resources necessary for improvement, timeline
management and capable results.
 Perform any other tasks as required.
 This positions reports directly to the COO

Education / Experience Requirements
 4 years degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc.
 10 years of experience in manufacturing medical devices Class II & III
 Experience with businesses regulated by 21 CFR part 820 and ISO 13485.

Nice to Have:

 Experience in balloon and catheter manufacturing
 Experience using statistical analysis tools.
 Experience applying engineering statistics principles.
 Technical writing and presentation skills.
 Development and validation of data processing tools.
 Experience with test method development and validation.
 Formal training in measurement system analysis.
Specialized Skills / Other Requirements
 Basic understanding and working experience of requirements applied to Manufacturing
Engineering Concepts.
 Familiarity with tools of Lean/Six Sigma Concepts and Process.
 Capable of supporting projects with operational results with minimal guidance.
 Experience designing, validating, and implementing production fixturing and equipment is a
plus.
Benefits:

• Training plans
• Medical Insurance
• Team Building
• Transport