MDR Human Factors Engineer

Date: Jul 13, 2021

Location: Remote, PA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3617


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


Vascular Access – Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The individual in this position will work in a highly collaborative, cross-functional team to guide and advise project teams in remediating the safety and performance as related to the Medical Device Regulation.  The focus is on creating safe, usable products that comply with MDR expectations and follow the human factors process at Teleflex.  As a member of the Quality Engineering team, the MDR Human Factors Engineer (HFE) will act as a subject matter expert to support the remediation of products by working collaboratively with interdisciplinary teams to offer guidance and coaching in planning, training and where applicable perform human factors activities.  The individual in this role should be familiar with the Medical Device Regulation, IEC-62366, and have an understanding of validating risk mitigations related to safety.  

Principal Responsibilities

•    Technically proficient subject matter expert and technical lead in human factors engineering responsible for guiding application of human factors engineering process, principles, analysis and usability as it relates to the Medical Device Regulation and safety and performance.
•    Ensures that development plans, processes and activities address human factors engineering activities and design requirements in order to maximize product usability and use-related safety.
•    Collaborates with development teams to optimize designs in consideration of use error risk and overall usability, and participates in identification, analysis, and evaluation of use-related risk and development of risk controls.
•    Develop a collaborative working relationship with a range of functions including but not limited to R&D, Marketing, Quality, Regulatory and Clinical Medical Affairs.
•    Provide guidance on planning and executing methodologically sound usability testing, data analysis, results, documentation and presentations following Teleflex HF processes and the guidelines of the MDR. 
•    Adhere to and ensure the compliance of Teleflex’s code of ethics, company policies, rules, procedures and housekeeping standards

Education / Experience Requirements

•    BS in Engineering, Human Factors Engineering / Ergonomics, Usability Engineering, Cognitive Psychology, Behavioral Psychology, Industrial Design or equivalent degree or related field with relevant work experience demonstrating acquisition and application of position-relevant skills.
•    Minimum of 3-5 years of professional Quality Engineering and/or Human Factors experience
•    Strong understanding of IEC-62366
•    Understanding of risk management processes
•    Understanding of design controls 
•    Understanding of the Medical Device and In Vitro Diagnostic Regulations (MDR & IVDR)
•    Excellent collaboration, communication, leadership, influencing, and presentation skills

Specialized Skills / Other Requirements


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.