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Medical Device Project Manager - Contract Manufacturer - Germany - flexible salary and good benefits
CLIENT is a global contract manufacturer for a range of technology products in medical devices, electronics, and telecoms sectors... and with a strong base of medical devices clients
ROLE is Medical Device Project Manager, coordinates the development process, and is responsible for ensuring that are projects are on customer time schedule....
oversees process of preparing new/modified products, ensuring compliance to internal and external customer requirements, FDA Quality System Regulations, and MDD (Medical Device Directive)
project manages process from development to successful volume manufacturing, and customer acceptance
acts as principal customer contact to document device input requirements
coordinates and influences activities of all engineering functions (electrical, mechanical, and manufacturing), including formal documentation required by medical device regulatory authorities
chairs design review meetings, and coordinates/influences activities of multi-functional team members
manages all phases of medical device design control process for assigned customers, to ensure that all internal/external requirements are met
ensures all input documents, risk analysis, FMEA, fault tree analysis, protocols and test reports for verification and validation processes are compliant to relevant regulatory agencies/authorities
engineering support of manufacturing operation for assigned customers after product release
coordinates future design changes for customer specific products
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