Design Quality Engineer

Position Summary: The Design Quality Engineer supports robust and compliant design control practices for sustaining engineering activities. The role serves as a quality representative on cross-functional teams, supporting compliance with regulatory requirements such as 21 CFR 820, ISO 13485, and EU MDR, as well as internal quality standards.

Background & Context: It also collaborates with Legal, Manufacturing, Operations, and Operations Transfer partners to support compliant development and product/process transitions. The Design Quality Engineer supports design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle., * 20% Support design verification and validation, risk management, and design reviews to help ensure product safety, performance, and regulatory requirements are met.

• 20% Review engineering design changes and provide quality input on documentation, traceability, and risk assessment; support continuous improvement of design processes, templates, and procedures.
• 40% Provide quality support for sustaining engineering projects, product improvements, and Operations Transfer activities, including transfer of products and processes into manufacturing and supplier environments.
• 20% Assist with quality deliverables for regulatory submissions, including 510(k), technical documentation, and IDE-related documentation; support audits, quality metrics, management review inputs, and other quality-related duties assigned by management.

• Working knowledge of ISO 13485, 21 CFR 820, and EU MDR.
• Experience with Design Controls and risk management, particularly as related to electronic device design.
• Statistical knowledge, including understanding of measurement uncertainty, and experience with statistical analysis and techniques.
• Detail-oriented and well organized, with excellent communication skills.
• Able to accomplish objectives with general supervision and escalate issues appropriately.
• Apply scientific principles and problem-solving, scientific rationale, and technical logic to engineering activities and development decisions.
• Evaluate, implement, and validate design changes to existing products; collaborate with Engineering, Legal, Manufacturing, Operations, and Operations Transfer teams to support development workflows and product/process transfers into manufacturing and supplier environments.
• Advanced Excel skills, including data analysis and reporting; advanced English communication skills, both written and verbal.