Beschreibung
Electrical - Engineer & Validations (Medical Device)For my client, part of a global Medical Device Manufacturer, I am currently looking for a specialist in Electrical Engineering, managing Complaint investigations, FMEAs and supports Projects related to Manufacturing, Validation and Process improvement.
Location: Central Switzerland
Duration: minimum 6 months, with potential extension
Activities: Technical Complaint Investigations, Validations, Process improvements
Main Responsibilities
- Responsible for Root Cause Analysis and complaint investigations for medical soft- and hardware applications
- Evaluate, review and approve Validation and Qualification plans and reports and Risk files
- Responsible for complete handling of Electrical and mechanical parts returned from the field for complaint investigations
- Analyze and report trends and statistical data
- Responsible for providing support and communication with external customers to resolve quality issues and other related product concerns
The profile
- Bachelor or Master's Degree in Electrical Engineering or similar education
- 2-3 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech or related industry
- Good knowledge of Industry regulations (ISO13485/ FDA 21CFR820 / GMP) or other highly regulated industry
- Expertise for failure investigations in soft- and hardware applications
- Experience in active device and knowledge of its Standards e.g IEC 60601
- In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
- Good communication skills
- Very good written and spoken knowledge in English and preferably in German
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.