Associate Director Engineering

Requirements

• Lead, develop, and mentor a high-performing human factors and usability engineering team.
• Build enterprise capability in human factors and usability by establishing scalable processes, tools, and best practices.
• Champion the integration of human factors, usability, and user-centered design into product development processes.
• Define and drive HF/UE strategy aligned with regulatory requirements, development milestones, and quality systems.
• Oversee planning and execution of formative and summative human factors studies in alignment with FDA, EMA, MDR, ISO 62366, and global standards.
• Ensure seamless integration of HF/UE activities within design controls and risk management (ISO 14971).
• Author and review HF/UE documentation including plans, use-related risk analyses, validation protocols, reports, and regulatory responses.
• Integrate use-related risk management across the product lifecycle to minimize on-market risk.
• Collaborate cross-functionally with Device Engineering, Regulatory Affairs, Quality, Medical, Packaging, Manufacturing, and Operations teams.
• Provide HF leadership in feasibility assessments and early-stage design decisions.

Benefits

• Comprehensive employee benefits package
• Retirement and Savings Plan with generous company contributions
• Group medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans