Human Factors Engineer

Position Overview

A global healthcare and life sciences organization is seeking a senior-level Human Factors Engineering professional to lead user-centered design initiatives across advanced medical devices and combination products. This role will focus on ensuring that products are intuitive, safe, and effective for healthcare professionals, patients, and caregivers operating in real-world clinical and home-use environments.

The successful candidate will play a key role in shaping product usability strategies across device hardware, digital interfaces, packaging systems, labeling, and training materials throughout the product development lifecycle.

Key Responsibilities

• Define and lead human factors and usability engineering strategies aligned with international regulatory expectations and industry standards.
• Direct user research activities and integrate customer insights into product development decisions.
• Establish usability and human-centered design requirements that align with intended product performance and patient needs.
• Conduct exploratory and formative research to evaluate user behavior, workflow patterns, and emerging interface concepts.
• Translate user insights into detailed experience requirements and interface specifications.
• Plan and execute usability studies assessing hardware, software, instructions for use, packaging, and training systems.
• Perform task analyses, use-error assessments, and risk evaluations to improve product safety and usability.
• Develop and maintain human factors validation plans, study reports, and usability engineering documentation.
• Support preparation of regulatory submissions and responses related to usability and human factors engineering.
• Collaborate with industrial design, engineering, quality, clinical, and regulatory teams throughout development programs.
• Oversee relationships with external research agencies, usability consultants, and design partners.
• Contribute to the development of internal usability engineering processes, templates, and best practices.
• Assist with internal and external audits related to product development and quality systems.
• Provide mentorship and technical guidance to junior human factors professionals and cross-functional teams.

Qualifications & Experience

Candidates should possess substantial experience in human factors engineering, usability engineering, biomedical engineering, industrial engineering, or a related discipline within the medical device, healthcare technology, or biotechnology sector.

Typical qualifications may include:

• Doctoral degree with significant professional experience in human factors or device development
• Master’s degree with extensive industry experience
• Bachelor’s degree combined with a long track record of leadership in usability engineering and product development

Preferred Technical Expertise

• Strong understanding of FDA, IEC, ISO, and other global usability engineering standards and regulatory guidance.
• Experience supporting design controls and regulated product development activities.
• Knowledge of use-related risk management methodologies for medical technologies.
• Familiarity with user-centered design principles across physical and digital product interfaces.
• Experience working on combination products, connected devices, or healthcare software systems.
• Strong communication and stakeholder management skills.

Work Environment & Travel

This role may involve occasional visits to research facilities, manufacturing sites, supplier locations, or clinical testing environments. The position can require domestic and international travel throughout the year for user studies, project collaboration, and supplier engagement.

Compensation & Benefits

The organization offers a comprehensive rewards package that may include:

• Competitive base salary
• Performance-based incentive opportunities
• Retirement savings plans with employer contributions
• Medical, dental, and vision insurance
• Paid time off, holidays, and sick leave
• Tuition reimbursement and professional development support
• Wellness and employee assistance programs
• Life and disability insurance coverage
• Volunteer or community engagement leave

Compensation will vary depending on experience, technical expertise, certifications, education, and geographic location.

Equal Opportunity Commitment

The employer is committed to fostering an inclusive and diverse workplace and provides equal employment opportunities to all qualified individuals regardless of legally protected characteristics.

Applicant Acknowledgment

By submitting an application, candidates confirm that the information provided is accurate and acknowledge that personal data will be handled in accordance with the organization’s applicable privacy and employment policies.

Employment Details

• Employment Type: Full-time, exempt position
• Work Arrangement: Regular employee role
• Location: Greater Boston / Massachusetts area