Associate Engineering Director, Combination Drug Product/Device

Role: Associate Director leading development and lifecycle management of drug/device combination products, including prefilled syringes and autoinjectors, primarily for injectable therapeutics across multiple modalities (peptides, proteins, antibodies, gene therapy). Objectives: ensure innovative device solutions, regulatory compliance, and seamless integration with drug products from early development through post-approval. Responsibilities: provide technical ownership of delivery devices and packaging, develop new delivery platforms, lead risk management and decision-making on device integration, coordinate with cross-functional teams (CMC, Regulatory, Quality, Manufacturing), oversee external partners, and monitor industry innovations. Requirements: BS/BA in Mechanical or Biomedical Engineering with 10+ years, MS/MA with 8+ years, or PhD with 5+ years of industry experience in combination product development; extensive knowledge of design controls, verification, validation, risk management, cGMP, and global regulatory standards (FDA, EMA, ISO). Preferred: experience with regulatory filings, external device development, human factors, and multiple therapeutic modalities. High-value specifics: expertise in injectable delivery systems, lifecycle management, and external partnerships. Work setup: not specified, likely collaborative with external vendors and cross-functional teams.