| Job Description: |
Technical/Functional
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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