Human Factors Manager
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Job Location:
San Jose, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Summary
The Human Factors Manager is a key leadership role responsible for guiding human factors strategy directing project execution developing talent overseeing client relationships and ensuring technical excellence. This role combines hands-on human factors expertise with people leadership project oversight and client-facing partnership.
You will lead a team of Human Factors Engineers manage multi-program portfolios and ensure that ClariMeds usability engineering practice maintains the highest standards of quality compliance and innovation.
Key Responsibilities
Team Leadership & Development
- Lead mentor and develop Human Factors Engineers across levels.
- Provide ongoing coaching technical guidance and performance feedback.
- Manage resource planning staffing and workload balancing across programs.
- Foster a collaborative high-performance team culture.
Human Factors Strategy & Technical Oversight
- Direct the planning and execution of formative and summative usability studies.
- Review and approve HF protocols test plans reports and usability documentation.
- Oversee development of usability risk analyses HF engineering strategies and regulatory documentation.
- Ensure adherence to FDA HF guidance IEC 62366 quality system requirements and industry best practices.
- Serve as an escalation point for complex human factors challenges across programs.
Project & Program Management
- Manage HF project portfolios ensuring quality timelines and budget alignment.
- Guide cross-functional teams to integrate human factors throughout product development.
- Direct complex multi-program HF strategies including outsourced or vendor-supported activities.
- Oversee coordination with third-party vendors contractors and partners to ensure seamless execution.
Client Partnerships & Business Growth
- Build and maintain strong client relationships across projects and strategic accounts.
- Lead or support business development through proposals scoping and client presentations.
- Represent ClariMed as a subject matter expert in client meetings and regulatory discussions.
Organizational Impact & Innovation
- Contribute to development and refinement of HF processes SOPs and quality standards.
- Drive process improvements operational efficiencies and methodological innovation.
- Participate in publications conference presentations and thought leadership initiatives.
- Support departmental planning budgeting and long-term organizational strategy.
Required Knowledge Skills and Abilities
- Deep knowledge of FDA Human Factors Guidance IEC 62366 and global regulatory expectations.
- Strong technical expertise in medical device usability engineering across the full product lifecycle.
- Demonstrated success managing HF teams and leading complex HF projects or programs.
- Excellent communication leadership and client relationship skills.
- Proficiency in developing HF strategies risk analyses and regulatory documentation.
- Experience with quality management systems and regulatory submissions.
- Strong business acumen problem-solving ability and decision-making skills.
- Experience presenting at conferences or contributing to industry publications is preferred.
Leadership Competencies
- Technical leadership and oversight
- Team development and coaching
- Strategic thinking and decision-making
- Effective delegation and project prioritization
- Resource and workload management
- Clear communication and influence
- Stakeholder and client engagement
- Quality management and continuous improvement
- Change management and adaptability
Minimum Qualifications
- Education: M.S./M.A. in Human Factors Engineering Cognitive Psychology Biomedical Engineering or a related field.
- Experience:
- 57 years of human factors experience in the medical device or combination-product industry.
- 23 years of experience managing or mentoring technical teams.
- Proven experience leading HF studies regulatory documentation and complex client programs.
Why Join ClariMed
- Opportunity to influence the design of innovative medical technologies.
- Collaborative environment with experienced HF UX engineering and regulatory professionals.
- Meaningful work that directly impacts patient safety and user experience.
- Growth opportunities including leadership development industry engagement and multi-site program ownership.
Required Experience:
Manager
Key Skills
- Employee Relations
- Succession Planning
- Employee Evaluation
- Human Resources Management
- Lean
- Lean Management
- Benefits Administration
- HRIS
- Payroll
- Employment & Labor Law
- Human Resources
- Manufacturing
About Company
About ClariMed, Inc. ClariMed is a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical pr ... View more
