Senior Usability/Human Factors Engineer

Main Responsibilities

• 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
• Achieve accurate reflection of human-system capabilities and limitations in system requirements
• Provide HFE/UE/Instructional Design input across functions to develop device design, packaging, labeling, and training requirements
• 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
• Design, plan, and execute formal usability testing protocols and studies (formative and summative), ensuring compliance with ISO and regulatory standards
• 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
• Perform risk assessments related to human factors and usability, identifying potential use-related hazards and mitigations
• Collaborate with cross-functional teams to ensure the effective implementation of risk mitigations
• 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

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

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 including 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