Role Overview:This role focuses on supporting Design History File (DHF) activities for medical device development projects, ensuring compliance with regulatory and quality system requirements. The engineer will be responsible for managing risk documentation, product specifications, and design control processes throughout the product lifecycle.
Key Responsibilities:- Support Design History File (DHF) activities for medical device development projects.
- Review, update, and maintain Global dFMEA documentation, ensuring risks are adequately identified, analyzed, and mitigated.
- Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
- Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
- Support creation and maintenance of product risk management files throughout the development lifecycle.
- Prepare, review, and update Product Characterization documents to define product performance and design intent.
- Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
- Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
- Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
- Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
- Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
- Participate in design reviews and provide 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 gaps in documentation 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 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 to convey direction and project plans with appropriate personnel from other departments.
