Description

You will own design verification and validation activities for medical devices.

Responsibilities

• Lead and support design verification and validation activities, including test method development and execution.
• Perform sample size selection and statistical data analysis to support design decisions and risk assessments.
• Conduct process capability studies and support design transfer to manufacturing.
• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.
• Review and approve design documentation including Design History Files (DHF) and risk management files.

Required Skills

• 8+ years of experience in Quality Engineering.
• Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820).
• Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366).
• Experience with statistical analysis tools like Minitab or JMP.
• CQE certification or equivalent qualification.
• Experience collaborating with R&D, Regulatory, and Manufacturing teams.

Key Skills

Education

Any Gradute