SENIOR DESIGN CONTROLS ENGINEER – COMBINATION PRODUCTS

We are looking a Senior Design Controls and Risk Management Engineer with 10 years of experience in the development of combination products, including injectables, prefilled syringes, auto-injectors, inhalation devices, and implantable drug-delivery systems. The successful candidate will lead the application of design controls, requirements engineering, risk management, traceability, verification and validation (V&V), and Quality by Design (QbD) principles, ensuring full regulatory compliance and design robustness.
This position plays a key role in product development and regulatory readiness by building and maintaining a robust Design History File (DHF) and integrating best practices aligned with FDA, ISO, and ICH standards.
Key Responsibilities:

Design Controls & DHF (21 CFR 820.30 / ISO 13485)

• Lead the structured implementation of design controls from concept through design transfer, in alignment with FDA 21 CFR 820.30 and ISO 13485.
• Maintain and oversee the Design History File (DHF) for a variety of combination product platforms including:
• Injectables and prefilled syringes
• Auto-injectors
• Dry powder and metered dose inhalers
• Implantable drug-delivery systems
• On-body delivery systems and wearable injectors
• Ensure DHF documentation is audit-ready and supports all regulatory submissions.

Requirements Engineering & Traceability

• Define and manage user needs, design inputs, system/subsystem requirements, and design outputs using structured methodologies.
• Ensure complete bi-directional traceability from user needs to risk mitigations, test protocols, and design verification results.
• Facilitate design input refinement, decomposition, and stakeholder alignment across functional teams.

Verification & Validation (V&V)

• Develop and lead verification and validation strategies tailored to complex combination products, ensuring design outputs meet design inputs and user needs.
• Collaborate with device engineering, human factors, analytical development, and clinical teams to ensure testing is robust and regulatory-compliant.
• Ensure V&V aligns with applicable standards:
• ISO 11608 (needle-based injection systems)
• IEC 62366 (human factors/usability)
• FDA guidance for combination products and human factors engineering

Risk Management (ISO 14971)

• Lead risk management activities including hazard analysis, design and process FMEA, use-related risk analysis (URRA), and fault tree analysis (FTA).
• Integrate risk controls into requirements and verification strategy.
• Ensure risk management files are current and fully aligned with product design evolution and lifecycle changes.

Quality by Design (QbD – ICH Q8–Q10)

• Apply QbD principles in the development of combination products with integrated drug and device components.
• Identify and manage Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and design space through collaboration with pharmaceutical development and manufacturing teams.
• Participate in design of experiments (DOE) and control strategy development to ensure robust product performance.

Regulatory Compliance

• Ensure compliance with combination product regulatory requirements, including:
• 21 CFR Part 4 (cGMP for Combination Products)

Please refer the Job description for details