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Verification and Validation Expert for Medical Devices (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Design
Projektbeschreibung
REFERENZNUMMER:
279334/4
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Software tester
279334/4
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Software tester
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik