Usability Engineer II — Medical Devices

NCBiotech; Morrisville (NC); On-site; USD 72,000 - 105,000; Full time

Job summary

Teleflex Incorporated in Morrisville, NC, seeks a Usability Engineer 2 to advance usability engineering across new product development and sustaining projects. You will collaborate with cross-functional teams to deliver rigorous usability outputs in a regulated design environment.

The role requires 2–4 years of usability engineering or design assurance experience, solid knowledge of FDA Human Factors, IEC 62366, and ISO 14971, and strong competence in planning, moderating, and documenting

Qualifications

• BS in Engineering or related field with relevant work experience.
• 2–4 years of usability engineering or design assurance in a medical device or other regulated industry.

Responsibilities

• 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 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.

Skills

FDA Human Factors

IEC 62366

ISO 14971

Design Controls

Moderating studies

Education

BS in Engineering

Usability/Ergonomics degree

Job description

Teleflex Incorporated in Morrisville, NC, seeks a Usability Engineer 2 to advance usability engineering across new product development and sustaining projects. You will collaborate with cross-functional teams to deliver rigorous usability outputs in a regulated design environment.

The role requires 2–4 years of usability engineering or design assurance experience, solid knowledge of FDA Human Factors, IEC 62366, and ISO 14971, and strong competence in planning, moderating, and documenting