Sr. Sustaining Engineer

Date: May 13, 2024

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10336

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

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.

Principal Responsibilities

• Manage multiple projects with competing priorities, maintaining strong communication with cross-functional stakeholders

• Support commercial manufacturing cost improvement activities, troubleshooting manufacturing issues, assisting with root cause investigation and inventory distribution for non-conformances

• Utilize engineering best practice tools when available, DMAIC, Design of Experiments, Root-Cause Analysis (Fishbone, 5 Whys, etc.)

• Utilize engineering acumen to identify and promote improvement activities across the organization

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

• 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

• 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.

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

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

Education / Experience Requirements

• Bachelors degree or above in engineering, physics, or a related scientific/technical discipline

• 7+ years of relevant experience within the medical device industry

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

Specialized Skills / Other Requirements

• Extensive experience in an area related to Medical Device Design (materials, mechanics, test methods, manufacturing methods, statistics)

• Strong-initiative to make improvements to increase workplace efficiency

• Proficient working with EU MDR regulations

• Demonstrated experience in the following areas: RoHS compliance, ISO 80369-7, and REACH compliance

• 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.

• 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

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 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.