Design Quality Engineer

Location: ~Indianapolis, IN~ (REMOTE)

Duration: 6 months


Design Quality Engineer


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.