Associate Director, Device Development

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

Qualifications And Skills

• Education & Experience: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline with 8+ years of relevant experience; advanced degree (MS or PhD) preferred
• Experience: Experience in combination product/device development (prefilled syringes and/or auto-injectors); experience supporting late-stage development through commercialization
• Technical Expertise: 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
• Leadership & Execution: 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; Willingness to travel (10–20%)

Pay

The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law.

Benefits

This role may be eligible for benefits and other compensation such as restricted stock units.