We’re seeking a Design Assurance Engineer to join an innovative medical device team. In this role, you’ll lead design assurance activities, support new product development, and ensure compliance with regulatory standards.
Key Responsibilities :
- Lead design assurance activities, including verification, validation, and risk management.
- Collaborate with cross-functional teams to implement best practices in design controls.
- Prepare and review technical documentation to support regulatory compliance.
Qualifications :
5+ years of experience in design assurance within the medical device industry.Strong knowledge of FDA, ISO, and IEC regulations and standards.Excellent problem-solving, analytical, and communication skills.