Associate Engineering Director, Combination Drug Product​/Device

About The Role

• Lead development and lifecycle strategy for drug/device combination products (including prefilled syringe and autoinjector presentations).
• Provide technical ownership for delivery devices and associated primary/secondary packaging from early development through commercialization and post-approval lifecycle management.
• Serve as subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration.
• Partner cross-functionally across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external partners to advance an injectable product pipeline.

• Lead strategic planning/execution for clinical and commercial combination product development.
• Own delivery devices and primary packaging/combination product elements across the product lifecycle.
• Develop innovative delivery device solutions (prefilled syringe, autoinjector, and other injectable platforms).
• Lead technical decision‑making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management.
• Ensure timely completion of development, V&V, manufacturing, and technology transfer deliverables.
• Partner with Quality, Regulatory, and external suppliers to meet global regulatory, cGMP, safety, and quality expectations.
• Identify, manage, and oversee external partners for device development, manufacturing, testing, and commercialization.
• Monitor emerging technologies and industry trends in injectable delivery systems.
• Support integration of delivery device and drug strategies across modalities (peptides, proteins, antibodies, gene therapy).

• BS/BA (10+ yrs) or MS/MA (8+ yrs) or PhD (5+ yrs) in Mechanical Engineering, Biomedical Engineering, or related field.
• Demonstrated expertise in medical device/combination product development, engineering, and commercialization.
• Experience with complex mechanical/electromechanical delivery systems (e.g., prefilled syringes, autoinjectors, on-body delivery).
• Advanced knowledge of design controls, design verification/validation, risk management, design transfer, and lifecycle management.
• Experience with drug/device integration, manufacturing scale‑up, technology transfer, and supplier/partner oversight.
• Thorough understanding of cGMP, quality systems, and global regulatory expectations (FDA, EMA, ISO).
• Knowledge of drug delivery technologies, connected health, human factors/usability, and emerging injectable trends.
• Ability to solve complex technical challenges and influence cross-functional teams.

• Support regulatory filings, health authority interactions, or commercial launch readiness.
• Experience with external device developers, contract manufacturers, testing labs, or component suppliers.
• Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies.
• Experience across multiple modalities (peptides, proteins, antibodies, gene therapy).

• Annual bonus (target 30% of earned base salary) and eligibility for equity-based long‑term incentive program.
• Retirement savings plan (with company match); paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).