Process Engineer
Teleflex

Expected Travel: Up to 10%

Requisition ID: 7431

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

This is a Coventry, CT based, hands-on, and on-site Engineering position, that will provide Teleflex Medical OEM Mansfield and Coventry with technical support and operating knowledge for our medical device operation. This role will conduct critical engineering functions such as validation, troubleshooting, and identifying and implementing process improvements. The engineer will work with cross-functional teams to support transfer of products between sites as well as into production. The role will be required to work with internal and external vendors. This position will focus on developing various processes, implementing those into production through validations and improving existing processes by working closely with R&D and Quality teams.

Principal Responsibilities

• Discover opportunities for waste reduction and capacity improvement and proactively drive solutions with and without capital investment.
• Present process and equipment recommendations for increased throughput.
• Engineering Change control work with project teams to identify issues and risks. During new product development integrate with Manufacturing Engineers, Design Engineers, Quality Engineers and the Production Department to ensure cost effective new product development and introduction into manufacturing.
• Lead/support process improvements.
• Aid in the develop of a continuous improvement culture by exemplifying actions to enhance quality and enterprise excellence.
• Introduce new equipment, products, and processes.
• Initiate new projects based on best practices and be the Project Leader for key improvement initiatives.
• Develop manufacturing Work Instructions.
• Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies and determination of efficiency goals.
• Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
• Develop protocols and coordinate validation of equipment and processes as required.
• Drives automation to replace the manual process as much as possible
• Analyzes and plans space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
• Confers with vendors defining User Requirements and arrange for purchase of equipment, materials, or parts.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Applies statistical methods to estimate future manufacturing requirements and potential.
• Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
• Establish processes based on product specifications.
• Develop and own Control Plans and pFMEA's.
• Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs.
• Maintain knowledge of new developments in manufacturing and design technologies.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Provide both remote and onsite support for troubleshooting manufacturing problems at Coventry and Mansfield sites as required.
• Perform other related duties and responsibilities, on occasion, as assigned.

Education / Experience Requirements

• Bachelor's degree in engineering required. Mechanical, Chemical, Biomedical or related technical field is preferred.
• Minimum 2 years, preferred 7 years experience in a manufacturing enviornment.
• Medical device manufacturing industry or other heavily regulated industry is preferred.
• Suture or textile experience preferred.
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Specialized Skills / Other Requirements

• Excellent oral and written communication skills are required. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations.
• Proven track record for project management, problem solving, sound decision making and project competitions; the ability to manage development programs across multiple locations and project teams.
• Experience in workflow optimization, work measurement, efficiencies.
• Recognized process improvement training (Lean, Six Sigma) preferred.
• Detail oriented with strong analytical skills.
• SPC (Statistical Process Control) knowledge.
• Familiar with FDA documentation requirements, QSR requirements for medical devices.
• Experience with Microsoft Word/Excel is required. Experience with Solidworks, Microsoft Project and MiniTab is preferred.
• Ability to prioritize and work independently.
• Behaviors consistent to support a quality and safety driven culture.

Wage Range/Rate: $69,100- $103,700 based on experience and qualifications

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.