Usability Engineer 2, Design Assurance

Teleflex; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Teleflex is seeking a Usability Engineer 2 in Morrisville, NC to drive usability activities for medical devices. You will partner with R&D, Quality, Regulatory Affairs, and Manufacturing to ensure safe, user-friendly products throughout development and lifecycle.

The role requires applying FDA Human Factors guidance, IEC 62366, and ISO 14971 within design controls, with 2–4 years of relevant experience in a regulated environment. Teleflex emphasizes quality and collaborative problem-solving.

Qualifications

• BS in Engineering or related field with relevant work experience in usability engineering.
• 2 to 4 years of usability engineering or design assurance in a regulated environment.
• Strong knowledge of FDA Human Factors guidance, IEC 62366, ISO 14971.

Responsibilities

• Develop protocols and perform usability engineering activities across product development in line with FDA/IEC/ISO guidance.
• Document use specifications, task analyses, user needs assessments, and risk analyses.
• Plan and conduct formative and summative usability evaluations, analyze results, and report findings.
• Collaborate with R&D, Quality, Regulatory Affairs, Clinical/Medical Affairs, Marketing, Manufacturing.
• Support investigations of usability-related issues and CAPA activities.
• Ensure compliance with company policies and design assurance procedures.
• Recruit clinicians for usability studies and moderate testing sessions.

Skills

Usability engineering

FDA Human Factors guidance

IEC 62366

ISO 14971

Design controls

Cross-functional collaboration

Education

BS in Engineering

Usability/Ergonomics

Job description

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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, LMA, Pilling, QuikClot, 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 Usability Engineer 2 supports the development, commercialization, and lifecycle management of safe, effective, and user-friendly medical devices by independently planning and executing usability engineering and human factors activities within a regulated design control environment. Working as part of the Design Assurance organization and cross-functional product development teams, this role partners with Business Unit stakeholders to deliver usability engineering outputs across new product development and sustaining projects.

• Ability to develop protocols and execute usability engineering activities across new product development and sustaining projects in alignment with FDA human factors guidance, IEC 62366, ISO 14971, internal design control procedures, and applicable quality system requirements.


• Conduct and document use specifications, task analyses, user needs assessments, identification of critical tasks, and use-related risk analyses to inform product design and risk management activities.


• Plan, execute, and document formative and summative usability evaluations, including protocol development, participant definition, data collection, study moderation, analysis, and report generation.


• Analyze usability study data to identify usability issues, residual risks, and opportunities for design improvement; recommend appropriate risk controls involving design, labeling, and training as applicable.


• Collaborate with R&D, Quality, Regulatory Affairs, Clinical/Medical Affairs, Marketing, Manufacturing, and Business Unit stakeholders to align usability objectives with project priorities, design requirements, and timelines.


• Collaboration in the recruitment of qualified clinicians for usability studies and moderate usability testing sessions in collaboration with engineering resources.


• Support investigation of usability-related issues, including root cause analysis and corrective/preventive actions (CAPA) or nonconformance activities, as assigned.


• Ensure compliance with company policies, the Code of Ethics, and procedural standards, maintaining high-quality output throughout all usability engineering activities.

Education / Experience Requirements

• BS in Engineering, Usability 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.


• 2 to 4 years of usability engineering or design assurance, preferably within the medical device or other regulated industry.

Specialized Skills / Other Requirements

• Strong working knowledge of FDA Human Factors guidance (Applying Human Factors and Usability Engineering to Medical Devices), IEC 62366 (Application of usability engineering to medical devices), and ISO 14971 (Medical devices — Application of risk management to medical devices).


• Solid understanding of design controls, product development processes, and the role of Design Assurance throughout the product lifecycle.


• Proficiency in planning, moderating, analyzing, and documenting formative and summative usability evaluations and related human factors deliverables.

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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 Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].