Concord · 1 month ago
Senior Human Factors & Usability Engineer (Medical Devices)
Concord USA is a consulting firm focused on enhancing customer experiences and optimizing operations through technology and data. They are seeking a Senior Human Factors & Usability Engineer to lead human factors strategy and execution for diagnostic medical devices, ensuring user needs and risks are anticipated and addressed throughout the product lifecycle.
Digital MediaMusicSocial Media
Responsibilities
Own the usability engineering roadmap across the product lifecycle—from early discovery to market release
Anticipate user needs, risks, and system-level implications before issues arise
Define the vision, strategy, and priorities for human factors activities and communicate them across cross-functional teams
Lead the creation and maintenance of Usability Engineering Files in accordance with IEC 62366 and FDA Human Factors guidance
Identify user profiles, tasks, critical use scenarios, usability risks, and system requirements
Translate user needs, UX research insights, clinical workflows, and business needs into actionable HFE requirements
Independently plan, design, and execute formative and summative usability studies (hardware, software, or integrated systems)
Manage external vendors and ensure high-quality execution, documentation, and data integrity
Analyze behavioral and physiological data to uncover deep insights that drive product decisions
Champion usability, safety, accessibility, and quality across R&D, Engineering, UX, Clinical, Regulatory, and Marketing
Facilitate workshops with customers, clinical partners, and internal teams to capture system-level insights and drive alignment
Proactively identify gaps, propose solutions, and push initiatives forward with minimal supervision
Serve as a subject matter expert for Human Factors Engineering within the organization
Mentor and guide junior team members on methodology, study design, analysis, and professional development
Present insights and recommendations persuasively to technical and non-technical audiences, including leadership
Qualification
Required
5–8+ years of applied Human Factors Engineering experience in the medical device or healthcare technology industry
Demonstrated ability to own the HFE strategy on complex products, anticipating challenges, proposing solutions, and driving execution
Deep knowledge of IEC 62366, FDA HFE guidance, Design Controls, and risk management (ISO 14971)
Proven experience planning, conducting, and documenting both formative and summative usability studies
Experience synthesizing behavioral, physiological, and qualitative data into actionable design recommendations
Familiarity with UX research or interaction design methods
Strong workshop facilitation skills and experience collaborating with customers, clinicians, and multi-disciplinary teams
Exceptional verbal and written communication skills
A proactive mindset with the ability to work autonomously, handle ambiguity, and deliver high-quality outcomes
Must be authorized to work legally in the US without sponsorship, now or in the future
Preferred
An advanced degree in Human Factors, Cognitive Psychology, Biomedical Engineering, or related fields is a plus
Experience with diagnostic devices, point-of-care systems, or integrated hardware–software medical products
Benefits
Health, Dental, and Vision Insurance: Comprehensive coverage to support your well-being.
Employer Contributions to Health Savings Accounts (HSA): Helping you save for medical expenses.
Flexible Spending Accounts (FSA): Options for healthcare and dependent care expenses, plus a $200 Lifestyle Spending Account (LSA).
Disability Insurance: Short- and long-term coverage, fully paid by the employer.
Life and AD&D Insurance: Employer-provided coverage, with options for additional voluntary coverage.
Employee Assistance Program (EAP): Access to personal and professional support resources.
Career Growth Opportunities: Pathways for advancement and skill development.
Team Engagement Activities: Regular team-building events and company-sponsored activities to foster collaboration and connection.
Company
Concord
CONCORD is the world’s leading independent music company.
Funding
Current Stage
Late StageTotal Funding
$5.96BKey Investors
Apollo
2025-07-22Debt Financing· $1.76B
2024-10-09Debt Financing· $850M
2023-10-25Debt Financing· $500M
Leadership Team
Recent News
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