The main responsibilities on the Design Control Engineer will be:
- Keep updated with ISO 13485 & ISO 14971.
- Hazard Analysis, DFMEA, PFMEA, UFMEA.
- Post market complaint data analysis and updating risk files.
- Experience in creating Design inputs / requirements, Design outputs, Design verification & Validation
- 5 years experience in Medical devices design & development, especially cardio vascular products
- Experience in working in Medical device - New product development & DHF Remediation projects
- Good understanding of ISO13485 & ISO14971 standards, 21 CFR Part 820 & EU MedDev Regulations
- Good understanding on product specific standards & safety standards
- Good understanding on product sterility, biocompatibility, labeling & packaging standards
- Experience in creating Risk Management plan, Hazard Analysis, DFMEA, PFMEA, Use FMEA, Software Hazard Analysis, Risk Management Report.
- Experience in updating risk management files based on post market surveillance feedback like complaints.
- Excellent communication skills (verbal and presentation skills).
Medical device Company based in Barcelona with High-tech product.
Attractive career path.