Senior Usability / Human Factors Engineer

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 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

Target base salary range

$131,000 - $151,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings

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

This is the national market pay scale.

Salary Range $131,000—$151,000 USD

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

We have 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.