Human Factors Engineer

BrioHealth Solutions is seeking a Human Factors Engineer to join its R&D team to support new product development, improvements on existing products, verification testing, and clinical trial of its current implantable heart pump BrioVAD and related mechanical circulatory support (MCS) technologies. As a Human Factors Engineer at BrioHealth Solutions you will play a crucial role in ensuring the safety, effectiveness, and usability of our products. You will work closely with cross-functional teams to integrate human factors principles into the design and development process, with a focus on enhancing the user experience for healthcare professionals and patients. Your expertise will help to identify and mitigate potential use errors, improve device ergonomics, and optimize user interfaces to support better clinical outcomes.

Reports to: VP of R&D, Systems Engineering

Responsibilities

• Collaborate with product development teams to define user requirements and design inputs based on user needs and clinical workflows.
• Conduct user research, including contextual inquiries, observations, and usability testing, to gather insights into user behaviors, preferences, and challenges.
• Develop user personas, scenarios, and use cases to inform design decisions and prioritize features that enhance usability and safety.
• Create and review human factors engineering documentation, including user interface specifications, task analyses, and risk assessments, to ensure compliance with regulatory requirements (e.g., FDA, ISO).
• Design and evaluate user interfaces for medical devices, including graphical user interfaces (GUIs), physical controls, labeling, and packaging.
• Conduct and assist in conducting formative and summative usability studies to assess device usability, identify potential use errors, and validate design improvements. Generate documentation of studies to meet regulatory requirements.
• Collaborate with industrial designers and engineers to prototype and iterate design concepts based on user feedback and usability test results.
• Apply human factors principles to optimize device ergonomics, minimize cognitive workload, and support error prevention strategies.
• Provide human factors expertise and guidance throughout the product lifecycle, from concept development and design verification to post-market surveillance and usability engineering.
• Work collaboratively with other internal design teams for new product development and introductions.
• Build cross-functional relationships across the organization where persuasive skills, negotiation skills, and considerable tact are required to gain support.
• Stay informed about industry trends, regulatory updates, and best practices in human factors engineering for medical devices.

Requirements

• Two years experience minimum in human factors engineering or usability engineering within the medical device industry, with knowledge of relevant regulations and standards (e.g., FDA Human Factors Guidance, ISO 62366). Proven track record of successful regulatory submissions.
• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Psychology, Industrial Design, or a related field. Master's degree preferred.
• Familiarity with medical device development processes, including design controls, risk management, documentation practices, and usability engineering activities.
• Proficiency in human factors tools and methodologies, such as usability testing, heuristic evaluation, cognitive walkthroughs, and usability risk assessment.
• Strong analytical and problem-solving skills, with the ability to translate user needs and insights into actionable design recommendations.
• Excellent communication and collaboration skills, with the ability to work effectively in multidisciplinary teams and communicate human factors concepts to diverse stakeholders.
• Experience with human factors analysis software, statistical analysis tools, and prototyping software (e.g., Adobe XD, MATLAB).
• Certification in Human Factors Engineering or Usability Engineering (e.g., Certified Professional Ergonomist, Certified Usability Analyst) is a plus.
• Knowledge of human-computer interaction (HCI) principles, user-centered design methodologies, and accessibility guidelines for medical devices.
• Strong interpersonal, communication and technical writing skills, with ability to work in a dynamic, multi-lingual environment.
• Up to 25% travel.

About BrioHealth Solutions Inc

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.