Director overseeing strategic and operational management of clinical solutions for Capital Blue Cross. Leading requirements, workflow design, and operational enablement for care management applications.
About the role
- Lead Human Factors activities ensuring compliance for combination products in medical device development. Collaborate with cross-functional teams for product launch and monitoring.
Responsibilities
- Coach and mentor junior scientists, fostering their professional growth and development within the organization.
- Lead Human Factors Project Work (Strategy and Execution), including, but not limited to Own HF strategy from early concept through validation and post-market for devices and combination products.
- Build HF plans and study roadmaps; select methods (user research, task/use-error analysis, risk mitigation, formative/summative usability testing).
- Turn user insights into design inputs for device UI, packaging, labeling, and IFU; guide intuitive, safe designs.
- Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF and manage risk.
- Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR).
- Maintain compliant HF documentation and traceability; ensure audit readiness.
- Monitor post-market use-related issues and drive corrective actions and training.
- Define and continuously improve HF process, standards, and templates per IEC 62366-1 and FDA guidance.
- Set clear governance (gates, criteria, documentation) for consistent HF quality across programs.
- Create reusable methods for needs discovery, user profiling, task analysis, and use-related risk assessment.
- Provide portfolio-level guidance for UI, labeling, and IFU to reduce use-related risk.
- Train cross-functional teams on HF practices and compliant documentation.
- Establish metrics and feedback loops (study quality, defects, post-market signals) to prioritize improvements.
- Maintain centralized HF libraries and tools to enable reuse and speed development.
Requirements
- B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management plus 15 years of related experience.
- Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
- Prefer to have experience in team and people management.
- Excellent communication, leadership, and problem-solving skills.
- Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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