Human Factors Engineer

Expected Travel: Up to 25%

Requisition ID: 10510

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.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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 creating safe, usable products that comply with regulatory expectations and follow the Human Factors (HF) process at Teleflex. As a member of the Design Assurance team, the Human Factors Engineer (HFE)will act as a subject matter expert to support the development of products by working collaboratively with interdisciplinary teams performing HF activities. The individual will provide training, coaching and guidance to other Design Assurance team members to facilitate their projects' HF/UE needs.

The individual in this role will support the design and evaluation of processes, products and

systems with respect to human factors engineering considerations as it relates to design controls, risk management and regulatory submissions.

This HFE will be proficient at task analysis, heuristic evaluations, formative usability testing, running research studies and validation tests, human factor regulations from the FDA, IEC & MDR, analyzing data, and leading project teams in translating findings into successful product designs.

Principal Responsibilities

• Technically proficient subject matter expert and technical lead in human factors engineering responsible for guiding lifecycle application of human factors engineering process, principles, analysis, and usability.

• Ensures that development plans, processes and activities address human factors engineering activities and design requirements to maximize product usability and use-related safety.

• Collaborates with development teams to optimize designs to mitigate use error risk and improve overall usability, and participates in identification, analysis, and evaluation of use-related risk and development of risk controls.

• Develops a collaborative working relationship with a range of functions including but not limited to R&D, Marketing, Quality, Regulatory and Clinical Medical Affairs.

• Drives the application of Design Controls and FDA Human Factors Engineering processes within the product development and sustaining project processes.

• Provides global business units guidance on planning and executing methodologically sound usability testing, data analysis, results, documentation, and presentations following Teleflex HF processes and the guidelines of the FDA, IEC 62366, & AAMI HE75.

• Trains project teams on the human factors specific elements of design controls.

• Provides technical guidance and/or design expertise including but not limited to:

o Supporting R&D, Clinical Medical Affairs, and other staff regarding human factors as a basis for design requirements.

o Developing the definition of system user interface design

o Developing the definition and development of labeling and training.

o Contributing to the user interface designs by providing guidance and ideas.

o Contributing to the design and development process by participating in design review meetings and reviewing and contributing to design inputs and risk analysis.

o Reviewing HF assessments included in regulatory submissions to the FDA or other regulatory bodies.

o Facilitating the completion of task analyses, use specifications, user interface specifications, formative and validation test plans and reports, as well as various FDA-specified documents that are part of the Usability Engineering File.

o Collaborate with designers, engineers, quality, regulatory, clinical medical affairs, the strategic marketing team, and business leaders to define detailed designs that meet user needs.

• Oversees recruiting process to identify qualified clinicians for formative and summative studies.

• Moderates formative and summative usability studies in concert with other Design Assurance engineering resources.

• Motivates teams to seek, utilize, and apply user insights throughout the product and service lifecycle.

• 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.

• Strong understanding of FDA Human Factors guidelines.

• Strong understanding of IEC-62366.

• Understanding of the role of design assurance engineering in the product lifecycle.

• Able to understand business goals and link them to design requirements and product architecture.

• Understanding of risk management processes.

• Understanding of design controls and the code of federal regulations.

• Understanding of the Medical Device and In Vitro Diagnostic Regulations (MDR & IVDR).

• Excellent collaboration, communication, leadership, influencing, and presentation skills.

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

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.