Mechanical V&V Engineer

Beschreibung

Mechanical V&V Engineer

Duration: 6 months

Location: Lausanne, Switzerland

Activities, Duties, Task and Responsibilities

Position Summary:

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 documentation to ensure that the disposables products meet the Quality, Reliability, Safety and Customer Satisfaction before commercial launch. This position shall ensure the following functions:

Primary Duties and Responsibilities:

• 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).

Mandatory Professional Experience/Knowledge

• 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, French and Italian an asset

Preferred Professional Experience/Knowledge

• 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

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.