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.

EDUCATION:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Chemical Engineering, or a related field.
• Master’s degree preferred.

EXPERIENCE:

• 10 years of experience in design assurance, product development, or quality engineering with combination products.
• Proven experience working with at least two of the following platforms: injectables, inhalers, prefilled syringes, wearable injectors, or implantable systems.

TECHNICAL SKILLS:

• Strong expertise in:
• FDA 21 CFR 820.30, 21 CFR Part 4, ISO 13485, ISO 14971
• ICH Q8–Q10 and applicable EU MDR expectations
• V&V planning and execution, risk analysis tools, usability engineering
• Experience with traceability and requirements management tools (e.g., Jama, DOORS, MatrixALM).
• Proficiency in documentation platforms such as Veeva, MasterControl, Greenlight Guru.

SOFT SKILLS:

• Detail-oriented with excellent organizational and analytical skills.
• Strong leadership and mentoring capabilities.
• Excellent written and verbal communication, especially for regulatory and cross-functional documentation.

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.