Usability Engineer II — Design Assurance & Human Factors

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

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.