Principal Sustaining Engineer

Date: Feb 19, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3459

 

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.

 

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

•    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
 

Principal Responsibilities

•    Coordinate Design Change activities 
•    Assess proposed Design and Process Changes for the impact to the organization; create evidence based project proposals
•    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
•    Provide R&D support for 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 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
 

Education / Experience Requirements

•    Bachelor’s degree in a relevant field.
•    Eight years of relevant experience required.
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously
 

Specialized Skills / Other Requirements

•    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 preferred.
•    Familiarity with electrical components and processes, capital equipment design and maintenance, IPC and IEC Standards (e.g. IPC-610, IPC-620-WHMA, IEC 60601, IEC 62304) and various other processes for electrical equipment fabrication and design preferred.
•    Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
•    A demonstrated ability to supervise technical personnel and lead product development activities to completion.
 

 

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.


Nearest Major Market: Minneapolis