For their site based in Switzerland, my client, an international growing Medical Devices company, is looking for a Validation and Verification Engineer, Medical Devices with strong experience in the development of Mechanical systems.
The ideal candidate will have a strong background in Electrical engineering, working on drug delivery devices. Have a minimum 5 years of experience with proven track record in the medical device Engineering and VV.
To be part of Product Assurance team within the Global Business Franchise Medical Devices.
Define Verification and Validation Plan for Medical software of Medical devices
Develop and execute medical software or Medical device system verification and validation protocols and scripts to ensure traceability and testing of all Design Inputs and critical product features
Generate verification and validation report summaries and logging issues.
Develop and executing process qualification protocols, such as IQ, OQ and PQ
Review approve supplier test plans, protocols and reports.
Utilize tracking software for defects/bugs change requests (e.g. ClearQuest, Bugzilla, Jira, HP)
Maximize efficiency of the test engineering process through a balance of automation of integration and test
Provide input to corrective action plans for defects found (CAPAs etc)
Perform regression analysis/testing and associated documentation on existing products undergoing change in design or manufacturing process
Communicate effectively with clients and team members, at all levels of the organization to solve complex project business, clinical, and technical challenges, using written and verbal communication.
Masters' degree (or equivalent) in Computer science, Telecommunication or Electronic engineering
Training to software development life cycle, preferably in the medical device domain (21 CFR 820, IEC 62304, FDA software guidelines, ISO 13485 and ISO 11608)
Minimum 5 years experience with proven track record in the medical device / engineering / VnV / Programming
Excellent technical problem solving skills with the ability to perform the root cause analysis
Excellent interpersonal skills and team spirited with the ability to resolve conflicts and motivate others
Excellent communication skills to lead with Business Partner and Supplier
Fluent in English, knowledge of French or / and German is a plus Competetive Location: Bern
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