Associate Director, Device Development
About The Position
As an Associate Director, Device Development, you will lead the development and lifecycle management of drug–device combination products, with a focus on injectable delivery systems such as prefilled syringes and auto-injectors. You will serve as the device subject matter expert (SME), accountable for design control execution, design history file (DHF) ownership, and integration of device strategy across CMC, regulatory, clinical, and manufacturing functions. This role operates at the intersection of device engineering, human factors, and pharmaceutical development, ensuring the delivery of safe, effective, and patient-centric drug delivery systems from late-stage development through commercialization.
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline with 8+ years of relevant experience; advanced degree (MS or PhD) preferred
- Experience in combination product/device development (prefilled syringes and/or auto-injectors)
- Experience supporting late-stage development through commercialization
- Strong knowledge of design controls, DHF, risk management (ISO 14971), human factors (IEC 62366), and verification/validation
- Understanding of combination product regulations (e.g., 21 CFR Part 4, ISO 13485)
- Experience with injectable drug–device interfaces and biologics delivery systems preferred
- Experience leading cross-functional teams in a matrixed environment
- Strong problem-solving, communication, and stakeholder influence skills
- Strong program management and ability to manage multiple priorities
- Experience managing vendors/CDMOs in regulated environments
- Commitment to quality, compliance, and ethical standards
Nice To Haves
- advanced degree (MS or PhD) preferred
- Experience with injectable drug–device interfaces and biologics delivery systems preferred
Responsibilities
- Lead end-to-end development of combination products (e.g., prefilled syringes, auto-injectors) through commercialization
- Define and execute device strategy, including design, verification, validation, and lifecycle management
- Translate user needs into product requirements and executable development plans with defined milestones, timelines, and risk mitigation strategies
- Lead human factors activities and integrate patient/provider insights
- Identify and resolve device–drug interaction challenges
- Own Design History File (DHF) and ensure compliance and inspection readiness
- Serve as SME for design controls and risk management in accordance with 21 CFR Part 4/820, ISO 13485, ISO 14971, and IEC 62366
- Lead design controls, risk management (e.g., FMEA, hazard analysis), and change control
- Support regulatory submissions and health authority interactions
- Ensure compliance with global combination product regulations and standards
- Support audits, inspections, and quality system activities
- Lead cross-functional teams across CMC, Regulatory, Quality, Clinical, and Supply Chain
- Manage external vendors, CDMOs, and development partners
- Provide technical support for manufacturing, tech transfer, and lifecycle management
- Communicate program status, risks, and decisions to stakeholders
- Manage timelines, deliverables, and continuous improvement efforts
Benefits
- A discretionary annual bonus may be available based on individual and company performance.
- This role may be eligible for benefits and other compensation such as restricted stock units.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
