Principal Scientist, Human Factors

Key Responsibilities:

• Manage a Human Factors team applying human performance knowledge and Human Factors techniques across the product lifecycle (customer needs, early concept screening, user profiles, task analysis, UI design, use error analysis, risk assessment/mitigation, usability testing, hazard analysis, and post-launch outcomes).
• Coach/mentor junior scientists.
• Conduct/manage human factors activities in a regulated environment: HF plans; partner with disciplines to define customer needs, intended use, and potential hazard/harm; provide product/packaging HF inputs; perform task/use error analysis; design instructions for use; run formative/summative studies; support regulatory submissions; address post-market surveillance and training needs.
• Strategically plan HF assessment for innovative product design.
• Collaborate cross-functionally (marketing, planning/PM, formulation, clinical, safety, regulatory, purchasing, manufacturing, packaging, labeling) to ensure regulatory compliance via risk management.
• Own/manage key development deliverables and records (e.g., protocols/reports, task analysis, use error analysis documents).
• Stay current on HF advancements and represent the organization externally.
• Support quality/GMP compliance activities for combination products and medical devices; other duties as needed.

• B.A./B.S in Human Factors/Ergonomics/Cognitive or Experimental Psychology/Sociology/Engineering/Chemistry/Business Mgmt plus 10 years related experience.
• Strong knowledge of human factors and device regulatory requirements/industry standards.
• Prefer team/people management experience.
• Excellent communication, leadership, problem-solving; ability to manage multiple priorities.

• Adaptability;
  Combination Products;
  Data Analysis;
  Finite Element Analysis (FEA);
  Innovative Thinking;
  Leadership Mentoring;
  Pharmaceutical Process Development;
  Professional Collaboration/Networking;
  Quality by Design;
  Regulatory Filings;
  Strategic Thinking;
  Technology Transfer.

• Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401k), paid holidays, vacation, and sick/compassionate days.