Job Summary
The Design Assurance Engineer collaborates with various teams to create and introduce innovative medical products while overseeing the documentation tied to the design history files. This role involves leading verification and validation processes, managing risk assessment tasks, and ensuring adherence to global regulatory requirements.
Responsibilities
- Collaborate with cross-functional teams in the development of new medical products.
- Manage design history file deliverables effectively.
- Drive and oversee verification and validation protocols.
- Conduct risk management activities associated with product development.
- Ensure compliance with international regulatory standards.
Qualifications
- Bachelor’s degree in engineering is a must.
- A minimum of 5 years of experience in product development, specifically in software and capital systems.
- Demonstrated technical expertise in both mechanical and software design.
- Experience in quality assurance for medical devices is essential.
