Manufacturing Engineer III

Position Summary

The Manufacturing Engineer III 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 III 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 III 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.  Experience with IQ/OQ/PQ and P/DFMEA is required, experience with Lean Principles is preferred.
 

Principal Responsibilities

•    Ensure production-specific metrics, such as yield, efficiency, etc. are met and sustained.
•    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).  
•    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. 
•    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.
•    Coordinate with production management in planning of and implementing the necessary technical changes required to sustain adequate production line capacity.
•    Provide technical leadership, mentoring, and supervision of Manufacturing Technicians.
•    Perform additional duties as requested to support the organization's needs.
 

Education / Experience Requirements

•    Minimum of a Bachelor’s degree in Engineering, preferably Mechanical Engineering
•    Minimum of 5 years’ experience supporting manufacturing, preferably medical devices.
•    Experience with FDA QSR process and validation documentation requirements a plus.
 

Specialized Skills / Other Requirements

•    Experience with IQ/OQ/PQ and P/DFMEA
•    Project management experience demonstrating the ability to meet schedule and budget targets.
•    Experience in the development of production test fixtures is desirable
•    Proficient in most common PC based applications (Word, Excel, etc.)
•    Knowledge of Agile and SAP a plus
•    Knowledge of six-sigma and Lean manufacturing a plus.
•    Excellent communication, organization, and interpersonal skills
•    Ability to complete tasks and projects with minimal direction
•    Ability to provide work direction/mentor Technicians and other Engineers
•    Ability to effectively communicate with a wide variety of internal and external customers and/or suppliers 

Lead
•    Has a Sense of Purpose & Inspires others
•    Has a desire & ability to “step up”
•    Takes accountability
•    Demonstrates critical judgement 

Engage
•    Communicates with Impact
•    Builds and sustains relationships 
•    Plans and Organizes 
•    Is present & available 

Develop
•    Develops Leaders
•    Builds High Performance people & teams
•    Invest in personal growth 
•    Develops Organization capability

Improve 
•    Creates value for the customer 
•    Demonstrates Continuous Improvement via results. 
•    Creates a culture of inclusion & involvement
•    Makes the tough calls when organizations are not performing 
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