Associate Director – Device Development, Prefilled Syringes & Auto-Injectors

Role Overview

• 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.
• Ensure compliance with FDA, EMA, and global HFE/usability requirements.
• 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.
• Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages.
• Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up.
• Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing.
• 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).

Requirements

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field.
• Associate Director: 8+ years of relevant experience.
• Director: 12+ years of relevant experience.
• Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors.
• Proven track record supporting late-stage development and commercialization.
• Strong knowledge of medical device design and development processes.
• Strong knowledge of human factors engineering / usability engineering.
• Strong knowledge of risk management.
• Strong knowledge of design controls and validation requirements.
• Strong knowledge of MSAT and manufacturing support for combination products.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.