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SuperProfMurten, CHSenior Product Development Engineer
RandstadLe locle, Neuchâtel, CHJobdescription
We are currently seeking a Senior Product DevelopmentEngineer for one of our clients in Canton ofNeuchatel.
If you are looking to work in adynamic and very friendly working environment and in the medicaldevices sector then this is for you.
Thisis an open-ended temporary contract
Please notethis vacancy requires fluency inFrench.
The Senior Product DevelopmentEngineer works as a member of sustaining engineering teamon
development of products in Integra’s drainageportfolio to the latest compliance standards.
TheSenior Product Development Engineer will be responsible for designmodifications of existing
products including fullproduct development cycle required by the latest qualitysystem.
Yourresponsibilities :
Understandingof Medical Device-New product development and SustainingEngineering Process,
Workingknowledge of Technical files and Medical Device product developmentprocess,
Knowledge ofcurrent European Medical Device directives (MDD / MDR) and CE Markprocess,
Experience inperforming / coordinating projects involving designprocess,
Experience in QMS,Tech File, DHF and Risk ManagementFile,
Understanding ofMedical regulatory standards is preferred (EU Regulations – MDD& MDR)
Knowledge on Part820, Part 11, ISO 13485, MDD / IVDD, IEC 60601x, IEC 62304, ISO14971,
Knowledge in DFMEA,PFMEA, GD&T and Design documentationprocesses,
Experience increation of Protocols, Testing and Verification including productusability isrequired,
Should be capableof owning the project ownership from beginning to projectcompletion,
Hardworking andshould be individual working for design and good Problem-solvingskills,
Should have goodcommunication skills to be able to communicate with steak holders,project managers, outsidevendors,
Experience with MSProject, MSOffice
Yourprofile :
Experience : minimum 5 years’ experience in mechanical design and new productdevelopment of medicaldevices
Education : Bachelor’s degree in Mechanical Engineering or similar engineeringdiscipline (Master’s degree in mechanical or biomedical engineeringpreferred)
Strongtime / project management skills (preferably experience usingMicrosoft Project or another project managementsoftware)
English and Frenchfluent