Senior Usability/Human Factors Engineer

About this role

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

Anteris is seeking a Senior Usability/Human Factors Engineer with expertise in usability engineering to join our dynamic team. As a Senior Usability Engineer, you will play a critical role in ensuring the safety, effectiveness, and user-friendliness of our innovative TAVR valve and delivery system. You will lead usability efforts, collaborate with cross-functional teams, and champion user-centered design principles throughout the product development lifecycle.

Main Responsibilities:

Usability Engineering Leadership

• Lead usability engineering activities

• Develop and implement usability engineering processes, strategies, and plans

• Drive the integration of human factors and usability considerations into all stages of product development

• Ensure Human-system capabilities and limitations are accurately reflected int eh system requirements, and HFE/UE/Instructional Design input is provided across functions to develop device design, packaging, labeling, and training requirements.

Prototyping & Evaluation

• Prototype novel solutions and validate against user needs

• Conduct user research, including user interviews, contextual inquiry, and usability testing, to gather insights on user needs and preferences

• Ensure design optimizations to enhance product usability and safety

• Analyze user feedback and incorporate findings into design iterations to optimize product usability

Usability Testing

• Design, plan, and execute formal usability testing protocols and studies (formative and summative), ensuring compliance with ISO and regulatory standards (e.g., FDA Human Factors Engineering guidelines).

• Collect and analyze data from usability testing to identify areas for improvement and propose design enhancements

• Collaborate with Systems engineers on simulated use platforms / tests to ensure relevance to real world usability experience

• Prepare documentation to support development activities, design controls, DHF, UEF, DMR including use specification, study protocol, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports for inclusion in regulatory filing and subsequent post-marketing needs

Human Factors Risk Assessment

• Perform risk assessments related to human factors and usability, identifying potential use-related hazards and mitigations

• Implement a risk-prioritized, fit-for-purpose approach to HF activities

• Collaborate with cross-functional teams to ensure the effective implementation of risk mitigations

Collaboration and Communication

• Provide usability engineering expertise throughout the product development lifecycle

• Collaborate closely with R&D engineering, marketing, clinical, and regulatory teams to align on usability objectives and requirements

• Communicate usability findings and recommendations effectively to stakeholders, ensuring that user-centered design principles are prioritized

Regulatory Compliance & Documentation

• Ensure compliance with relevant regulatory standards and guidelines, including ISO 62366, ISO 14971, and FDA Human Factors Engineering guidance

• Generate comprehensive usability engineering documentation, including usability plans, reports, and usability files

Continuous Improvement

• Stay updated on the latest industry trends, standards, and best practices in usability engineering and biomedical engineering

• Recommend and drive improvements in usability processes and practices

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Human Factors Engineering, or a related field required

• Minimum of 5 years of experience in usability engineering for medical devices. Experience with interventional technologies and procedures such as valve replacement, stent placement, cardiac ablation, or similar is required. TAVR experience…