Description
We are looking for a
Verification and Validation Expert for medical devices (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Zurich region
Branch: Wettbewerber
Your tasks:
- Verification and Validation Expert leads and manages the End to End test activities related to Medical Drug Delivery Devices to ensure that the final product meet the intended use
- Define Verification and Validation strategy for Drug Delivery Devices
- Defining the End-to-End System Test Requirements of projects ensuring traceability and testing of all Design Inputs and critical product features
- Review and approve supplier test plans, protocols and reports
- Develop and execute medical device system verification and validation protocols and scripts
- Setup a Defect and Test management tool
- Plan and implement quality assurance and quality control for all test activities related to a project
- Manage all test activities related to a project in term of resources, timing, costs, quality and risk
- Generate verification and validation report summaries and Known anomalies issues
- 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
Your qualifications
- Masters' degree (or equivalent) in Mechanical engineering 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)
- Experience in Verification and Validation of complex Medical device development including electronic and mechanical elements
- Leadership skills and ability to secure commitment from other stakeholder's
- Knowledge of Medical drug delivery devices with embedded software is a plus
- Fluent in English, knowledge of French and/or German is a plus
Skills:
- Software tester
Keywords: V&V Verification Validiation Test cases