Design Quality Engineer
TechnicalFunctional
Skills Strong understanding of Medical Device Product Development Process and Design Control requirements. Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards. Strong knowledge of Design Controls and medical device product development. Experience with Design History File (DHF) development, review, and remediation.
Hands-on experience with Risk Management activities including: o dFMEA o uFMEA o Preliminary Hazard Analysis (PHA) o Hazard Analysis Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971. Experience with Design Verification and Validation (V&V). Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements. Experience preparing and reviewing: o Product Specification Documents (PSD) o Product Characterization documents o CTQ (Critical-to-Quality) documents Experience with CAPA, Nonconformance, and root cause investigations. Familiarity with PLM systems such as Windchill, or Teamcenter. Experience with Cockpit Cognition DHF Build and DHF traceability management. Strong documentation, technical writing, and audit support skills.
Roles & Responsibilities Support quality activities throughout the product development lifecycle. Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements. Lead and support risk management activities including dFMEA, uFMEA, and PHA updates. Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs. Support Design Verification and Validation planning, execution, and documentation reviews. Review Product Characterization, Product Specification (PSD), and CTQ documents. Participate in design reviews and ensure compliance with
Design Control processes. Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages. Conduct DHF gap assessments and support remediation activities. Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams. Support CAPA investigations, root cause analysis, and implementation of corrective actions. Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures. Support internal audits, customer audits, and regulatory inspections. Drive continuous improvement initiatives related to design quality and risk management processes.
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