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Description
Position Summary: The DHF Specialist is responsible for ensuring that medical devices are developed in compliance with regulatory standards such as FDA 21 CFR 820.30 and ISO 13485. This role involves maintaining and managing the Design History File (DHF), ensuring traceability between design inputs, outputs, verification, validation, and risk management. The engineer will work closely with cross-functional teams to facilitate design reviews, manage design changes, and support regulatory submissions. Key Responsibilities: Maintain and manage the Design History File (DHF), ensuring it is complete, organized, and audit-ready. Ensure traceability between design inputs, outputs, verification, validation, and risk management. Ensure compliance with FDA, EU MDR, and ISO standards. Prepare documentation for regulatory submissions (e.g., 510(k), PMA, EU MDR). Work closely with Client’s R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Clinical teams. Facilitate design reviews and ensure proper documentation of decisions and changes. Support the creation and maintenance of risk management files in accordance with ISO 14971. Participate in FMEA (Failure Modes and Effects Analysis) and other risk assessment activities. Manage design changes and ensure updates are reflected in the DHF. Evaluate the impact of changes on product safety and effectiveness. Support or lead design verification and validation activities. Ensure test protocols and reports are properly documented and linked to design requirements. Required Skills: Strong attention to detail and documentation skills. Ability to work in cross-functional teams. Familiarity with PLM systems (e.g., Windchill, Agile), document control systems (e.g. Vault), and QMS software. Critical thinking and problem-solving skills. Excellent communication and collaboration skills. Must be a Team Player. Qualifications: Bachelor’s/Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. 5+ years of experience in medical device design or quality engineering. Show more Show less
