Director, Device Engineering

Reports To: Executive Director, Device Engineering

FLSA Status: Exempt

Job Type: Full-time

About Accord:

Accord is a global provider of generic and specialty pharmaceuticals. Our focus on a rapidly expanding portfolio of affordable generic medicines of exceptional quality standards has made us one of the fastest growing US generic and specialty companies.

The Director, Device Engineering is a strategic, hands‑on technical leader responsible for the end‑to‑end development, industrialization, and lifecycle management of drug–device and biologic–device combination products. This role ensures compliance with FDA (21 CFR Part 4, 21 CFR 820), EMA/MDR, ISO 13485, ISO 14971, IEC standards, and other global regulations.

The Director will lead cross‑functional engineering activities that drive design, development, verification, validation, technology transfer, and ongoing commercial support for Accord’s device and combination product portfolio. This includes strong emphasis on design control, human factors engineering, risk management, supplier oversight, and manufacturing readiness from concept through post‑market support.

The following duties are considered essential to the role. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Lead end to end development, manufacturing, and lifecycle management of combination products (e.g., prefilled syringes, autoinjectors, on body injectors) in full compliance with global regulatory requirements.
• Serve as the device subject matter expert across all development phases, including design development, verification, validation, risk management, human factors, and process validation.
• Define system architecture, assess design feasibility, lead material selection, guide prototyping, and ensure high quality technical documentation.
• Ensure seamless integration of drug product, device components, packaging, and delivery systems through effective collaboration with cross functional teams.
• Conduct and oversee design for manufacturing (DFM), reliability engineering, tolerance analysis, DOE, and design reviews.
• Develop and maintain design requirements, Design History Files (DHF), and Technical Files in alignment with Accord’s ISO 13485 Quality Management System.
• Lead risk identification, analysis, evaluation, and mitigation using ISO 14971 methodologies (e.g., hazard analysis, design FMEA, process FMEA).
• Provide oversight of human factors engineering, including use related risk analysis, formative evaluations, and summative validation studies.
• Develop and execute verification and validation test plans, protocols, and reports.
• Provide technical direction for device test method development and validation, test fixture design, and laboratory execution.
• Oversee external partners such as CMOs and test laboratories to ensure successful GMP production, assembly, and testing.
• Author, review, and provide technical inputs to regulatory submissions for drug device combination products.
• Serve as device SME in regulatory agency interactions, partner audits, and technical due diligence.
• Partner with CMOs and global suppliers to ensure robust clinical and commercial manufacturing readiness.
• Lead technical investigations for deviations, complaints, and nonconformances; drive root cause analysis and corrective/preventive actions.
• Support ongoing process monitoring, scale up, and continuous improvement initiatives.
• Lead post market engineering activities, complaint investigations, change management initiatives, and product sustainability programs.
• Evaluate and implement design improvements, cost reductions, and supply chain optimizations while maintaining regulatory compliance.
• Provide onsite troubleshooting and support at manufacturing or supplier locations as needed.
• Occasional domestic and international travel required.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully meet the…