Role Overview:This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing, updating, and maintaining critical documentation such as dFMEA, uFMEA, and Preliminary Hazard Analysis (PHA), ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities: - Support and manage Design History File (DHF) activities for medical device projects.
- Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks.
- Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures.
- Support the creation and maintenance of product risk management files throughout the development lifecycle.
- Prepare, review, and update Product Characterization documents, Product Specification Documents (PSD), and Critical-to-Quality (CTQ) documents.
- Support the development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
- Ensure robust traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
- Collaborate cross-functionally with Design, Quality, Regulatory, Manufacturing, and Project Management teams.
- Participate in design reviews, providing technical input on risk management and DHF compliance.
- Support engineering change assessments and associated documentation updates.
- Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
- Identify documentation gaps and recommend corrective actions.
- Support audits, inspections, and compliance activities related to design control and risk management documentation.
- Contribute to continuous improvement initiatives for product development and design control processes.
- Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
Required Skills: - Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
- Experience in supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
- Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
- Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.
- Strong written and verbal communication skills for project plans and inter-departmental collaboration.
Qualifications: - Experience in medical device development environments, particularly with Design History File (DHF) and risk management processes.
