Description

You will own quality engineering for Class III vascular medical devices, ensuring compliance with 21 CFR 820 and driving design quality throughout the product lifecycle.

This role is on-site.

Responsibilities

• Manage Design Quality activities for new product development, including design integration and DHF remediation.
• Ensure strict adherence to 21 CFR 820 regulatory requirements across all device stages.
• Support quality engineering for vascular devices such as catheters, stents, and guidewires.
• Conduct design audits and quality assessments to mitigate risk and ensure compliance.
• Collaborate with engineering teams to resolve quality issues and close design files.

Required Skills

• 5+ years of experience in medical device quality engineering.
• Strong background in New Product Development (NPD) and Design Quality.
• Deep knowledge of 21 CFR 820 Quality System Regulations.
• Hands-on experience with Design History File (DHF) creation and remediation.
• Experience with Class III medical devices, specifically vascular devices (catheters, stents, guidewires).
• BS Degree in Engineering or a related science.

Preferred Skills

• Proven track record in vascular device design integration.

Key Skills

Education

Any Gradute