Tasks and Responsibilities
- Write and update specification documents for different medical device projects.
- Perform literature reviews to have a better understanding of the different applications of similar products on the market.
- Review applicable standards (IEC, MDSAP) and ensure that they are taken into consideration in specifications and other documents.
- Plan, write and maintain risk analysis documentation related to medical devices.
- Define and maintain project schedules.
- Manage certification projects (IEC) and coordinate with certification laboratories.
- Assist engineering in the development of verification protocols and their execution (e.g. includes verification of printed circuit boards).
- Coordinate transfer to production of new medical devices.
- Prepare, manage and review device history files (DHR).
- Make sure quality system processes are followed during design and production activities.
- Write, review and maintain assembly and verification instructions related to electrical components.
- Manage the review, investigation and update of nonconformity reports and correction plans from production (related to electrical aspects).
- Follow-up on component availability and plan required changes with engineering.
- Assist engineering in manufacturing prototypes.