Human Factors Engineer

ABOUT WARWICK CONSULTING

Warwick Consulting provides comprehensive engineering services to the medical device industry, specializing in non-compliance remediation, software assurance, cybersecurity, and human factors engineering. Our work also spans software as a medical device (SaMD), verification and validation (V&V), and research and development (R&D) support.

Since 2011, we’ve supported clients in over 25 therapeutic areas and facilitated the commercialization of more than 35 medical devices.

We are currently expanding our Human Factors Engineering (HFE) capabilities with the launch of a state-of-the-art usability testing lab in the Boston area, designed to support both traditional medical device testing and emerging areas like AI-enabled healthcare.

ABOUT THIS ROLE

We are seeking an early-career Human Factors Engineer to join our team and play a key role in both client-facing HFE work and the build-out and commercialization of our new usability lab.

This is a unique opportunity for someone early in their career to gain hands-on experience across:

·      Medical device usability engineering

·      Clinical simulation environments

·      Lab design and operations

·      IEC 62366 compliance

ESSENTIAL FUNCTIONS

The Human Factors Engineer is primarily responsible for user-centered research activities related to product design. This position will work under direction of senior personnel to support product development teams by:

·      Providing research and design inputs related to human capabilities and product interactions, including but not limited to user needs and requirements, use specifications, task analyses, and use-related risk analyses.

·      Designing, executing, and reporting on formative and summative usability studies, contributing to product evaluations and design validation efforts.

·      Producing HFE documentation for regulatory submission.

This position will also support the growth of Warwick’s HFE team and service offerings by:

·      Supporting the opening and operationalization of a new usability lab, including coordinating with vendors, managing the acquisition of equipment, and setting up simulated clinical and home environments.

·      Collaborating with marketing team members to generate HFE content.

·      Producing HFE assets such as templates, SOPs, and white papers.

This position requires 0-10% travel, domestic and international. Travel expectations subject to change based on client need.

REQUIRED QUALIFICATIONS AND EXPERIENCE

·      Bachelor’s degree in Human Factors Engineering, Engineering Psychology, Biomedical Engineering, Systems Engineering, or related field (completed by Summer 2026).

·      At least 1-5 years of HFE experience (including internships and co-ops) with a bachelor’s degree or 0-5 years of HFE experience with a master’s degree.

·      Human factors or usability experience with medical devices, including familiarity with existing IEC usability standards, AAMI human factors standards, and/or FDA human factors guidance.

·      Demonstrated experience with user-centered design methods and conducting usability evaluations, including facilitation and observation.

·      Knowledge and experience with clinical user research.

·      Strong project management and organizational skills.

·      Strong written and verbal communication.

·      Ability to work with multi-functional development teams, both in person and remotely.

·      Demonstrated ability to independently scope, plan, and execute complex projects or workstreams from high-level objectives with minimal direction.

·      Comfortable with a hybrid work environment, including the ability to travel to the Boston-area lab on a regular basis (must live in the greater Boston area or be willing to relocate by August 2026).

PREFERRED QUALIFICATIONS AND EXPERIENCE

·      Bachelor’s or master’s degree in Human Factors Engineering.

·      Experience applying HFE to software as a medical device (SaMD) or health software.

·      Demonstrated experience authoring and maintaining human factors/usability engineering documentation, including development of usability engineering files (UEF) with clear traceability between user needs, use-related risks, formative evaluations, and summative (validation) study outputs.

·      Excellent technical writing skills with experience writing clear, submission-ready documentation for regulatory audiences.

·      Advanced understanding of IEC usability standards, AAMI human factors standards, and/or FDA human factors guidance.

·      Experience with UX research and/or UX/UI design.

·      Ability to create wireframes, screen prototypes, and/or computer simulations.

COMPENSATION

·      Commensurate with experience

·      40 hours/week, 6-month W-2 contract

·      Potential conversion to full-time employee based on performance and business needs