Senior Design Quality Engineer

Summary :



We are looking a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products, including infusion systems and drug-device delivery platforms. This role works closely with R&D, Manufacturing, and Regulatory teams to ensure products are developed and manufactured in compliance with medical device quality and regulatory requirements.

This is a hands-on quality engineering role focused on design controls, verification & validation, risk management, and product lifecycle quality support.

Roles & Responsibilities:

• Support quality activities across the product lifecycle for electromechanical and combination medical devices.


• Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development.


• Review and approve design i...