Mechanical V&V Engineer

LausanneTemporaireChimie, Pharma, Biotechnologie2019-06-25Master / Université
Urgent JOB: we are recruiting on a temporary contract an experienced mechanical engineer with V&V expertise for the medical device

Mechanical V&V Engineer

Your Responsibilities

Main purpose of the role:
As member of the Verification and Validation team, the Mechanical V&V Engineer will be responsible for the Verification and Validation of disposable products and for complex electro-mechanical medical device products. A major job function for this position will be to perform hands-on requirement and V&V ensure that the disposables products meet the Quality, Reliability, Safety and Customer Satisfaction before commercial launch.

• Support in design activity (feasibility phase, specifications, prototype, DOE)
• Support sustaining activities: tests related to NCs, ECFs, CAPAs
• Perform product verifications and validations (V&V plan and report)
• Management of V&V disposables laboratory: CSV, Qualification of laboratory equipment, ensure compliance and maintenance of appropriate instruments/ test benches used on laboratory environment
• Support in manufacturing process approval and validation (e.g. FAT, SAT, IQ, OQ, PQ, FAI, Gage R&R) with DHF and DMR maintenance (e.g. Risk Analysis, PFMEA, DFMEA)

Your profile

Must have:
• Mechanical Engineering, Material Science Engineering, Biomedical Engineering degree.
• Understanding of Process Validation
• Fluid / solid mechanics
• Good practice of Microsoft office (Word, Excel)
• Excellent technical documentation reading and writing skills.
• Fluent in English.

• Knowledge of medical device regulations 21 CFR820 and/or ISO 13485
• Knowledge Design Verification and Validation
• Statistical data analysis, Minitab experience an asset
• Good Manufacturing Practices
• Good Laboratory Practices
• Strong interpersonal skills, excellent oral and written communication
• Team player on internal/external, national/international teams
• Autonomous, must be able to work with minimal supervision.

Votre contact

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