Design Control Engineer - Primary Packaging and Medical Devices

Position Overview The position contributes to the execution of strategic focus areas and provides technical leadership for the lifecycle management of primary packaging systems, medical devices, and combination products associated with legacy product portfolios.Key ResponsibilitiesSupport the selection, evaluation, improvement, qualification, and implementation of new and existing primary packaging materials, medical devices, and combination products.Provide scientific and technical support to maintain the design integrity of commercially released combination products.Coordinate cross-functionally with Regulatory Affairs, Quality Assurance, Production, Manufacturing, and Supply Chain to ensure effective post-launch support, including design and supplier changes, complaint investigations, root cause analysis, and compliance-driven projects.Apply expert knowledge of the regulatory landscape to ensure compliance with Quality Management Systems such as ISO 13485, 21 CFR 820 Design Controls, ISO 14971 risk management, and EU MDD/MDR requirements.Ensure design control activities are performed in accordance with scientific principles, regulatory and internal guidelines, legal requirements, and quality standards, while maintaining data integrity and scientific consistency across all verification and validation activities.Promote rigorous data analysis using advanced statistical techniques and communicate technical findings to cross-functional teams.Compile and maintain Design History Files (DHFs), including documentation related to verification, validation, clinical trial support, and commercial manufacturing.Maintain design control documentation for legacy products and integrate market feedback—including product technical complaints—into the DHF.Support the resolution of issues arising from internal audits, regulatory inspections, and notified body interactions, preparing responses and corrective actions as required.Support the creation, review, and approval of design control documentation such as protocols, reports, verification and validation documents, FMEAs, risk management plans, change management plans, and design review documentation.Provide clear, effective, and transparent communication to internal and external stakeholders.Qualifications and ExperienceMinimum of 10 years of experience in device development within the pharmaceutical or biotechnology industry.Extensive involvement in change control and post-market surveillance activities, including ISO 14971, MDR, and CAPA processes.Strong focus on lifecycle management and continuous improvement of existing products.Solid scientific background in primary packaging systems and drug delivery technologies.Experience in design control documentation, risk management, and SOP development.Flexibility in working hours; however, a minimum of 60% on-site presence is expected.