Design Assurance Engineer (DHF & Risk Management)

Job Title: Design Assurance Engineer (DHF & Risk Management) 
Location: Indianapolis, IN

Role Description: Roles & 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 the creation and maintenance of product risk management files throughout the product development lifecycle.
• Prepare, review, and update Product Characterization documents to define product performance and design intent.
• Create and maintain Product Specification Documents (PSDs), ensuring alignment with design requirements and customer needs.
• Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
• Support the 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 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, standards, and requirements.
• Establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
• Support DHF gap assessments, document linking, metadata management, and compliance reviews.
• Demonstrate familiarity with digital DHF structures, document hierarchies, and traceability matrix development.
• Support DHF remediation projects and the migration of legacy design documentation into Cockpit Cognition.
• Communicate project plans, technical direction, and updates effectively (both written and verbal) with personnel across multiple departments.

Essential Skills

• Strong knowledge of Design History File (DHF) documentation and Design Control requirements.
• Experience with Design Failure Mode and Effects Analysis (dFMEA) and Use Failure Mode and Effects Analysis (uFMEA).
• Knowledge of Preliminary Hazard Analysis (PHA) and product risk management processes.
• Experience preparing and maintaining Product Characterization Documents, Product Specification Documents (PSDs), and Critical-to-Quality (CTQ) documentation.
• Understanding of Design Inputs, Design Outputs, Verification, Validation, and design traceability.
• Ability to establish and maintain traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation documentation.
• Experience supporting DHF gap assessments, remediation activities, metadata management, document linking, and compliance reviews.
• Familiarity with Cockpit Cognition and digital DHF document management systems.
• Knowledge of medical device design control processes and applicable quality and regulatory requirements.
• Experience working with cross-functional teams, including Design, Quality, Regulatory, Manufacturing, and Project Management.
• Strong technical documentation, analytical, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities while maintaining high-quality documentation.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong attention to detail and commitment to documentation accuracy and compliance.