Manufacturing Engineer III

Teleflex•Chelmsford, MA

53d

About The Position

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 and new IAB Willow catheter. The Manufacturing Engineer III primary function is to provide day to day support for the new Willow catheter new product development injection molding processes and assembly processes 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.

Requirements

5 years of experience with a bachelor's degree OR 3 years of experience with a master's degree
Minimum of 3-5 years' experience supporting manufacturing, preferably medical devices.
Experience with FDA QSR process and validation documentation requirements a plus.
Experience with IQ/OQ/PQ and P/DFMEA
Experience with Injection molding equipment and processes (especially in Medical Devices)
Experience with Resins and other Polymers used in Injection Molding
Experience with Tooling used in the injection Molding processes
Project management experience demonstrates 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

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.