Sr. Sustaining Engineer

Sr. Sustaining Engineer

Date: Sep 30, 2024

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :11089

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com .

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

We are seeking a Sr. Sustaining Engineer to join our R&D group. This position will play a key role in handling design and process alterations of existing products and managing engineering requirements for distributed products. If you are someone who enjoys gaining technical expertise on a wide variety of new products, all while working across an organization to achieve goals, we would love to hear from you. This person will have the opportunity to collaborate with teams from various business units.

Principal Responsibilities

• Provide engineering support to design and/or process alterations to existing products

• Manage engineering activity required to support products through the commercialized life cycle

• Manage and execute engineering requirements for distributed product

• Coordinate Design Change and Process Change activities

• Lead commercialized product change project teams and maintain design history files

• Assess proposed Design and Process Changes for the impact to the organization; create evidence-based project proposals

• Prepares project schedules and coordinates engineering activities to ensure outputs meet specifications as well as corporate goals and objectives

• Develop design inputs and design outputs for changes to existing product or new distributed product

• Develop new test methods and/or alter existing test methods

• Provide R&D support for verification, qualification, and validation studies on existing products

• Support risk management activities and risk management reviews on existing products

• Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.

• Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.

• Support regulatory approvals and responses to regulatory questions for existing products.

• Ensure design change and process change activities, processes and practices are in compliance with internal quality system requirements.

• Maintain and supplement design history files that are thorough and accurate for existing product

• Interview, select, train and evaluate performance of new hires

• Mentor, train and supervise sustaining engineering technicians

• Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary

Education / Experience Requirements

• Bachelor degree or above in a relevant field, or a related scientific/technical discipline

• 6 years of relevant experience within the medical device industry

• Demonstrated project management skills and ability to coordinate multiple projects simultaneously

Specialized Skills / Other Requirements

• Excellent collaborator and communicator of technical concepts to a large audience

• Ability to work cross functionally and across multiple levels within the organization to support initiatives, obtain stakeholder feedback, and drive critical decisions of projects

• Must possess knowledge, understanding and skills in: product designs/concepts, catheter materials, project management, documentation, and a working knowledge of quality systems and medical device regulations

• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required

• Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications preferred

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 10 %

WORKING ENVIRONMENT:

☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

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: 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, 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.

© 2024 Teleflex Incorporated. All rights reserved.