Design + Human Factors Engineering Senior Director

Jobgether

11h • $163,500 - $264,000

About The Position

This role provides a unique opportunity to lead the design and human factors engineering function within a global delivery and device organization. The Senior Director will guide product innovation, ensuring patient-centered and compliant solutions across medical devices, combination products, and packaging programs. You will oversee a top-tier team, develop strategic direction, and partner with cross-functional stakeholders to align delivery and device strategies with organizational goals. The position requires balancing technical leadership, regulatory expertise, and people management to drive high-quality outcomes. You will influence internal processes, external collaborations, and industry best practices, shaping both the organization and the broader medical device landscape. Travel may be required for strategic initiatives, regulatory interactions, and key partnership activities.

Requirements

• MS in Engineering with 10+ years or PhD in Engineering with 5+ years of relevant delivery device design and development experience.
• Experience interacting with regulatory agencies and supporting regulatory submissions for medical devices and combination products.
• In-depth knowledge of human factors protocols, usability studies, and reporting requirements.
• Prior experience leading and developing high-performing technical teams.
• Demonstrated ability to influence and lead cross-functional teams in complex, regulated environments.
• Strong understanding of device/drug regulations and standards (e.g., CFR 820.30, ISO 13485, ISO 14971, IEC 62366).
• Excellent communication, interpersonal, and strategic leadership skills.
• Proven experience managing suppliers, alliance partners, and multi-disciplinary project teams.

Responsibilities

• Lead and grow a high-performing team of design and human factors engineers, providing coaching, mentorship, and career development support.
• Ensure human capabilities, limitations, and performance risks are appropriately reflected in system requirements and design decisions.
• Oversee the execution of design and human factors activities in compliance with regulatory standards and quality systems (e.g., IEC 62366, ANSI/AAMI HE75).
• Collaborate with cross-functional stakeholders including commercial units, regulatory, manufacturing, and digital health teams to align delivery strategies and projects.
• Manage project milestones, budgets, and resource forecasts while identifying and mitigating risks.
• Establish and maintain effective relationships with external vendors, regulatory bodies, and alliance partners.
• Act as an opinion leader in human factors and contribute to industry standards, policy development, and regulatory guidance.

Benefits

• Competitive salary range: $163,500 – $264,000, with eligibility for company bonus programs.
• Comprehensive benefits package including medical, dental, vision, life insurance, and prescription drug coverage.
• 401(k) and pension plan participation.
• Flexible benefits including healthcare/dependent care FSAs.
• Paid vacation, leave of absence options, and employee well-being programs.
• Opportunities for professional development, career growth, and leadership within a global, innovative organization.
• Exposure to cutting-edge delivery device technology and impactful healthcare solutions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees