Associate Director / Director, Device Development (Prefilled Syringes & Auto-Injectors)

We are seeking an experienced Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization.

Requirements

• Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization
• Define and execute device development strategies, including design, verification, validation, and lifecycle management
• Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies
• Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs
• Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies
• Provide subject matter expertise in biomedical engineering and device technologies
• Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing
• Independently manage external partners, including device manufacturers, design firms, and testing laboratories
• MSAT & Manufacturing Support: Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages
• Support regulatory submissions (e.g., IND, BLA) with device-related content
• Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)
• Partner with Quality to ensure design controls and risk management processes are implemented effectively

Benefits

• Competitive salary
• Benefits package
• Supportive and inclusive team environment
• Opportunities for professional growth and development