Senior Design Controls Engineer

No C2C please!!!!!!!! No C2C please!!!!!!!!No C2C please!!!!!!!!No C2C please!!!!!!!! Senior Design Controls Engineer – Combination Products We are looking a Senior Design Controls 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) 21 CFR 820, 210, 211 EU MDR, ISO 13485, ISO 14971 FDA guidance on Human Factors, Postmarket Surveillance, and Part 11 Provide design documentation and support for regulatory filings: IND, NDA, ANDA, 510(k), PMA, and Technical Files for global markets. Cross-functional Leadership & Mentorship Collaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to integrate design control requirements. Act as SME during internal and external audits. Provide guidance and mentorship to junior engineers and cross-functional teams on best practices in design assurance and documentation. 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. Job Type: Contract Pay: $60.00 per hour Expected hours: 40 per week Work Location: Remote