Senior Scientist, Drug​/Device Combo Products; Hybrid

Senior Scientist, Human Factors Responsibilities:

• Lead and manage human factors activities across the full regulated product design/development lifecycle (human factors plan; customer needs; intended use; hazard/harm identification; product/packaging design inputs; task and use error analysis; instructions for use; formative/summative studies; regulatory submission materials; post-market surveillance and training needs).
• Partner cross-functionally (marketing, program management, clinical, safety, regulatory, manufacturing, packaging/labeling) to integrate HF, manage risk, and ensure regulatory compliance.
• Maintain regulatory compliance records/databases; support internal HFE process consistency, efficiency, and compliance.
• Lead regulatory deliverables: HF protocols/reports; linkage to ISO 14971 risk management; hazard/use-related risk analyses; submission materials (FDA, EU MDR).
• Perform scientific literature reviews and database research; synthesize findings to support HF research.

• B.A./B.S. in Human Factors, Ergonomics, Cognitive/Experimental Psychology, Sociology + 3 years related experience, or M.A./M.S. in a related discipline.
• Strong knowledge of human factors and device regulatory requirements/industry standards.
• Prefer experience coaching/mentoring.
• Excellent communication, leadership, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

• Analytical Method Development;
  Creativity;
  Data Compliance; ISO 13485;
  Policy Compliance/Procedure Adherence;
  Product Development;
  Product Launch Planning; (also listed technical areas such as GD&T, manufacturing processes, mechanical design/testing; pharmacology/pharmacovigilance).

$–$ salary range; annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, 401(k), paid holidays/vacation.