Manufacturing Engineer II

Position Summary

The Manufacturing Engineer II will have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. Provide support as an engineering resource on cross functional teams focused on sustaining and implementing continuous improvements to Teleflex catheter product lines.  These product lines include Intra-Aortic Balloon (IAB) catheters, pacing catheters, thermodilution catheters, cholangiography catheters, sheath introducers, Berman angiographic balloon catheters, and Wedge pressure catheters. 

The Manufacturing Engineer II primary function is to provide day to day support of the catheter manufacturing floor operations from an engineering perspective.  The engineer will drive investigations tied to non-conforming product as well as processing general Non-Conformance (NC) tasks.  In addition, the Manufacturing Engineer II is responsible for driving 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

•    Lead investigations tied to Non-Conformances, Complaints, and CAPA. Produce as team member or leader of investigative team as required for leadership or engineering technical assistance.
•    Lead engineering actions identified though production visual management boards
•    Source, plan, present, and deliver significant projects targeted at reducing waste, increasing productivity, and reducing stress on the operations and its operators.   Demonstrate competency in the use of the tools of improvement – Six Sigma and Lean Tools associated with the Teleflex Production System (TPS).  
•    Design/modify/fabricate tools and fixtures to support the needs of manufacturing and provide for improvement opportunities.
•    Create and update manufacturing and engineering documentation (Work Instructions, SOPs, Specifications, Engineering Drawings, etc), and perform training as necessary.
•    Demonstrated competence in process qualification and validation activity.  This activity includes authoring and executing validation plans, engineering studies, Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA and corporate guidelines. 
•    Keep track of industrial trends in applications and technologies, including practices and engineering tools. Maintain knowledge of technology changes to be able to implement in Teleflex operations
•    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 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.
•    Adhere to all Company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Minimum 4 year degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc. 
•    Manufacturing Engineering or equivalent experience required in a regulated environment.  5 Year minimum experience.  3 Year minimum with advanced degree.
 

Specialized Skills / Other Requirements

•    Basic understanding and working experience of requirements applied to Manufacturing Engineering Concepts. 
•    Competence with tools of Lean/Six Sigma Concepts and Process. 
•    Capable of leading projects with operational results with minimal guidance. 
•    Competence in MS Office including MS Project and Visio
•    Excellent verbal and written communication skills, including presentations (internal and external customers)
•    Experience designing, validating, and implementing production fixturing and equipment is a plus. 
•    Experience with Solidworks is a plus.
•    Must possess high degree of organizational skills
•    Ability to deliver superior results in team environments
•    Ability to plan and prioritize activities for self and for others on teams supported
•    Ability to work independently to meet assigned project deadlines and assist others in meeting their target deadlines.
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