Job Description
Seeking an experienced Design Assurance Engineer to support product development and ensure compliance with medical device regulations. This role leads design verification/validation, risk management, and design control activities while driving continuous improvement in quality practices.

Responsibilities

• Lead design assurance activities, including verification, validation, and risk management.

• Prepare and maintain design control documentation (DHF, DMR, technical files).

• Develop and execute test protocols/reports aligned with regulatory standards.

• Analyze data and support regulatory submissions.

• Oversee design reviews and provide team feedback.

• Monitor regulatory updates and industry best practices.

Qualifications

• Bachelor’s in Engineering (Master’s preferred).

• 5+ years of design assurance experience in medical devices.

• Strong knowledge of FDA, ISO, and IEC standards.

• Skilled in risk management, design controls, and statistical analysis tools.

• Excellent communication, problem-solving, and teamwork skills.