Sr Human Factors Engineer I

Role Summary

Senior technical engineer responsible for leading human factors engineering (HFE) strategies for device combination products (e.g., pre-filled syringes and auto-injectors) from feasibility through post-market, including requirements definition, risk analysis, formative and summative usability studies, and documentation for regulatory submissions.

Responsibilities

• Lead or support HFE strategies and activities for device combination product design and development across all stages (feasibility, clinical development, registration, post-market), including risk analysis, usability studies, and training development.
• Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses.
• Educate team members and internal stakeholders on the HFE development process and approach.
• Interface and coordinate with HFE consulting firms to execute human factors activities.
• Improve internal HFE processes to ensure consistency, compliance, and efficiency.
• Ensure all HFE work is performed in accordance with SOPs and regulatory requirements.

Qualifications

• Required: B.S. in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience.
• Or: Required: M.S. in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 4+ years of relevant experience.
• Required: Experience leading HFE efforts in support of combination product development and commercialization, with working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.
• Required: Excellent verbal, written, and interpersonal communication skills.
• Required: Demonstrated ability to facilitate interface with medical device vendors and HF consulting firms.
• Required: Demonstrated ability to analyze data and identify relevant design updates.
• Required: Ability to write clear, concise, high-quality documents.
• Required: Ability to exercise judgment within ambiguity and established procedures to determine and take appropriate action.
• Required: Experience managing team expectations for project timelines and realistic timeline estimates for HFE activities.
• Required: Deep knowledge of regulatory and compliance requirements for HFE and combination product risk management.
• Required: Ability to collaborate effectively with cross-functional teams and influence key stakeholders.

Education

• B.S. in mechanical engineering, chemical engineering, bioengineering, or related field with 6+ years of relevant experience; OR
• M.S. in mechanical engineering, chemical engineering, bioengineering, or related field with 4+ years of relevant experience.

Skills

• Strong knowledge of human factors engineering for medical devices and combination products
• Proven ability to facilitate vendor and consultant collaborations
• Analytical mindset with data-driven design updates
• Clear, concise technical writing and documentation
• Cross-functional collaboration and stakeholder influence