Senior Biomedical Engineer - Usability

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.
We are seeking a Senior Biomedical 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.
Key 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 in the 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, 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.
• 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.

Qualifications:

• Bachelor's degree in Biomedical Engineering, Human Factors Engineering, or a related field required. Graduate degree preferred.
• Minimum of 5 years of experience in usability engineering for medical devices, with a focus on Class III devices. Interventional experience required; TAVR experience preferred.
• Strong knowledge of human factors engineering principles and regulatory requirements.
• Experience with user-centered design methodologies, usability testing, and risk management.
• Proficiency in usability engineering software tools.
• Excellent written and verbal communication skills.
• Strong project management and leadership skills.
• Ability to work effectively in cross-functional teams.

Health and Wellness Offerings

• Medical, Dental, and Vision Offerings
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays
• Paid Vacation
• Employee Assistance Program
• Inclusive Team Environment

Note: We may require proof of COVID-19vaccination to comply with the state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. Wehave a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization.Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.