Job Description: Design Controls Engineer (Contract)


About the Role

The Design Controls Engineer will be responsible for ensuring that all activities related to design controls, risk management, verification/validation, and design transfer are compliant with ISO , FDA CFR , and MDSAP requirements. Unlike traditional medical device companies. This role will act as the central owner of design compliance, bridging those functions into our QMS.



What You'll Do

● Establish and own Our company's Design & Development procedures (ISO §, including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software

● Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated.

● Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software.