Job Title: Human Factors Engineer

Job Description

We are seeking a skilled Human Factors Engineer to conduct human factors engineering work and research for medical devices and regulated healthcare products. The ideal candidate will have extensive experience in usability studies, product evaluation, and risk analysis.

Responsibilities

• Perform human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable products.
• Design and execute usability evaluations to ensure safe and easy product use.
• Lead the development of a Use-Related Risk Analysis as part of the risk file for the products.
• Develop and communicate Human Factors project scope, plans, tasks, and deliverables with program teams; manage time to meet project deadlines.
• Report pertinent information at key milestones through clear, concise oral and written communications.
• Develop product prototypes for user interface evaluation and validation in partnership with other R&D teams.
• Direct and coordinate all human factors activities necessary to complete a major product development program or several small projects with minimal direction.
• Lead efforts to develop processes and procedures that align with company initiatives and FDA/international human factors standards.
• Provide technical supervision to less experienced human factors engineers and may manage a small work group.
• Present and advise on human factors topics across the organization.

Essential Skills

• Bachelor's Degree in Engineering (Master's degree preferred).
• 7+ years of relevant experience in human factors, preferably in the medical device industry.
• Experience in HFE principles and methodologies.
• Proficiency in user research, prototyping, formative and summative product evaluation, and use-related risk analysis.
• Knowledge of IEC 62366-1, IEC 60601, and FDA HF/Usability Guidance Document.

Additional Skills & Qualifications

• Experience with medical devices.
• Experience with kidney dialysis or related product lines.
• Local to Minnesota.

Work Environment

This role will be working on-site in Plymouth and will require 25% travel for destination case studies, which typically come in waves of travel. The average work week includes three days on-site and two days remote. Flexible hours are available, and any weekend work can be compensated with PTO days.