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Concord · 3 weeks ago

Senior Human Factors Engineering Consultant

United States

Full-time

Remote

Senior Level, Lead/Staff

$60/hr - $70/hr

10+ years exp

Concord is an execution company focused on enhancing customer experiences and optimizing operations. They are seeking a Senior Human Factors Engineering Consultant to lead human factors strategy and execution for diagnostic medical devices, ensuring usability and compliance with industry standards.

Software

Work & Life Balance

No H1B

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

Human Factors EngineeringIEC 62366FDA HFE guidanceUsability studiesRisk management (ISO 14971)Digital product usabilityStakeholder coordinationVendor managementWorkshop facilitationProactive mindsetVerbal communicationWritten communication

Required

10+ years of applied Human Factors Engineering experience in the medical device or healthcare technology industry

Demonstrated ability to own the Human Factors Engineering strategy on complex products, anticipating challenges, proposing solutions, and driving execution

Deep knowledge of IEC 62366, FDA HFE guidance, risk management (ISO 14971), and Design Controls

Strong experience with digital product usability (software, apps, integrated systems)

Proven experience planning, conducting, and documenting both formative and summative usability studies

Ability to manage multiple projects simultaneously, prioritize effectively, and maintain timelines

Skills in stakeholder coordination and vendor management for usability studies

Experience developing training materials and improving related workflows

Familiarity with UX research or interaction design methods and the ability to influence early-stage design

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

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 overall well-being.

Employer Contributions to Health Savings Accounts (HSA) - For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.

Flexible Spending Accounts (FSA) - Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.

Disability Insurance - Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.

Life and AD&D Insurance - Employer-provided coverage of with options for additional voluntary coverage.

Employee Assistance Program (EAP) - Support for legal, financial, and personal challenges.

401(k) Retirement Savings - 1% employer match.

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 a technology consultancy building connected customer experiences backed by powerful AI & analytics and underpinned by secure IT foundations.

Founded in 1999

Hopkins, Minnesota, USA

1001-5000 employees