Associate Engineering Director, Combination Drug Product/Device
$173,600–$237,000 year
On-site · San Diego, California, United States
Job Summary
Lead development and lifecycle strategy for drug/device combination product development (including prefilled syringe, autoinjector presentations) from clinical through commercialization. Provide technical ownership for delivery devices and associated primary and secondary packaging, and serve as the device and combination product subject matter expert on cross-functional CMC and program teams. Drive design controls, verification/validation, risk management, manufacturing readiness, and lifecycle management; oversee external partners for device development, testing, and technology transfer; ensure global regulatory, cGMP, and quality expectations are met; collaborate with Quality, Regulatory, External suppliers, and other functions to advance injectable product pipelines across modalities.
Required Qualifications
- BS/BA in Mechanical Engineering, Biomedical Engineering, or a related field, with 10+ years of industry experience
- MS/MA in Mechanical Engineering, Biomedical Engineering, or a related field, with 8+ years of industry experience
- PhD in Mechanical Engineering, Biomedical Engineering, or a related field, with 5+ years of industry experience
- Demonstrated expertise in medical device or combination product development, engineering, and commercialization
- Experience developing combination products leveraging complex mechanical or electromechanical delivery systems, preferably including prefilled syringes, autoinjectors, on-body delivery systems, or related injectable platforms
- Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management
- Experience with drug/device integration, manufacturing scale-up, technology transfer, and external partner or supplier oversight
- Thorough understanding of cGMP, quality systems, and global regulatory expectations for combination products and medical devices, including FDA, EMA, and applicable ISO standards
- Current knowledge of drug delivery technologies, connected health solutions, human factors/usability engineering, and emerging trends in injectable product development
- Proven ability to solve complex technical challenges, make sound risk-based decisions, and influence cross-functional teams
- Strong communication, collaboration, and leadership skills in a matrixed environment
- Preferred Qualifications: experience supporting regulatory filings, health authority interactions, or commercial launch readiness for combination products
- Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies
- Experience across multiple modalities including peptides, proteins, antibodies, or gene therapy products
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