What are the responsibilities and job description for the Senior Human Factors Engineer position at SoTalent?
Job Title: Human Factors Engineering - Associate Engineering Fellow
Location: Lexington, Massachusetts, United States
Type: Full Time
Our Client is seeking a senior-level Human Factors Engineering leader to drive human‑centered design for medical devices and combination products. This role is pivotal in ensuring product interfaces—spanning hardware, software, packaging, labeling, and instructional materials—enable safe, effective, and intuitive use by intended users in real‑world settings.
Key Responsibilities
- Lead and execute end‑to‑end Human Factors and usability strategies aligned with global regulatory expectations
- Define and oversee user research approaches in compliance with established quality systems
- Develop product- and system-level Human Factors requirements aligned with target product objectives
- Conduct exploratory user research to uncover insights, behaviors, and emerging design trends
- Translate user needs into actionable user experience and interface specifications
- Plan and conduct formative and summative usability studies across physical, digital, and instructional artifacts
- Perform task analyses, known use problem assessments, and use-related risk evaluations
- Lead development of usability validation protocols, reports, and supporting documentation
- Prepare Human Factors summary reports and usability engineering files in accordance with international standards
- Manage and qualify external partners supporting Human Factors, industrial design, and user research activities
- Support regulatory interactions and responses related to Human Factors and usability
- Contribute to the development and continuous improvement of Human Factors procedures, templates, and best practices
- Embed Human Factors rigor within design controls and product development processes
- Collaborate closely with engineering, clinical, regulatory, quality, and manufacturing teams
- Support internal and external audits as a subject-matter expert
- Mentor and develop junior Human Factors professionals and technical leads
Qualifications
- PhD with 10 years of relevant experience or Master’s degree with 13 years of relevant experience or Bachelor’s degree with 15 years of relevant experience.
- Relevant backgrounds include Human Factors Engineering, Biomedical Engineering, Industrial Engineering, or related disciplines within regulated medical device or healthcare environments.
Additional Information
- Role is primarily analytical, with periodic hands-on involvement in user research, testing, or site visits
- May require work in clinical, laboratory, or manufacturing environments
- Up to 20% annual travel, including domestic and international locations
Salary : $154,400 - $242,550