Mechanical Design Engineer

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von: Swissels Engineering & Life Science Services | localité: LausanneN: SwisselsEngineering&LifeScienceServices

Mechanical Design Engineer /Medical device 

 
Mission:
Design and development of innovative, highly integrated micro-mechanical systems and sub-systems, including force and movement transmission modeling and calculating.
Dimensioning and tolerancing calculations of innovative micro-mechanical assembly and sub-systems.
Testing and improvement of these micro-mechanical systems and sub-systems in order to reach the product specifications and reliability.
Finalize and optimize the micro-mechanical systems design, ensuring its safety, performance and manufacturability.
Assembly of prototypes for development and for verification and validation tests
Define the micro-mechanical systems specifications and associated testing plan.
Write parts specifications and draw plans
Drives the micro-mechanical systems risk analysis (both design and process FMEAs).
Imagine, define, and implement micro-mechanical systems production and testing processes.
Creation of assembly and test instructions
Participate in the validation of the manufacturing processes in order to obtain FDA clearance (Medical Device GMP).
Management of sub-projects including material and parts supplying and stock management
rtner closely with other team members to successfully bring prototypes in clinical study.
Supervision of trainees on development projects.
Independently manage third-party vendors including automation solution providers. 
 
 
 
Profil :  
-Minimum of Bachelor’s in (Micro-) Mechanical Engineering or equivalent.
? Advanced knowledge in Solidworks requested, use of surfaces an asset.
? Excellent knowledge of micro-mechanical assembly tolerancing
? Good knowledge in production techniques and automation.
? Good knowledge in plastic injection ? Experience in writing requirements and technical specifications.
? Knowledge in medical manufacturing validation, GMP an asset.
? Experience with measuring systems, fluid measurement an asset. ? Experience in working in an ISO 13485 environment is a plus.
? Knowledge of laser and ultrasound welding is a plus.
? Fluent in French, excellent in English, German is a plus.?
Demonstrated ability to work within a fast-paced start-up environment in a small team setting.
? Strong organizational and time management skills

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