we are seeking for a V&V Engineer, to join the QA, RA & CA department.
As a V&V Engineer, your principal task will be to verify and validate Medical Devices. You will be responsible for HW & System testing including test protocols and reports.
The main responsibilities within this role:
Design, develop and execute system Verification and Validation test procedures.
Responsible for writing detailed, comprehensive, and well-structured V&V test protocols and reports ensuring requirements coverage and traceability.
Analyzing issues and failures in the system.
Work in a highly multidisciplinary and complex technical environment and lead testing of cross-functional projects (with emphasis on mechanical and electro-optical aspects)
Being involved in the reliability and integration tests for prototypes under development
Coordination and management with external testing laboratories
Define and maintain the Verification & Validation plans.
Plan and arrange the work, schedules, and equipment required for testing and evaluating standard and special devices.
Identify, investigate, and document all findings raised during testing.
Work closely with cross functional team members including R&D (System, SW&HW), QA, RA and Product departments.
Requirements: Education: Bachelors degree in Engineering (Electrical/Mechanical/Biomedical/Systems) or equivalent
At least 5 years of experience in design & testing related roles, preferably in start-up companies.
At least 3 years as a V&V engineer working on a multidisciplinary medical device a must.
Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA a must
Experience with engineering processes, including tests protocols and reports development, criteria definition based on standard investigation and statistical analysis.
High proficiency of English, including good technical writing and verbal communication skills.
Proven ability to work in accordance with good practices and established methodologies.
Ability to correspond to fluctuating priorities, timelines and demands under a high-pressure environment.
Ability to work in a highly multidisciplinary and complex technical environment.
Ability to work as team member.
Open minded, creative and out-of-the box thinker.
Experience with Matlab/Python an advantage.
This position is open to all candidates.