V&V Engineer

Augmedics, a medical device start-up developing an Augmented Reality Guided Surgery System, is seeking for a V&V Engineer, to join the QA, RA & CA department.

As a V&V Engineer in Augmedics, 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.
  
  

• Education: Bachelor’s 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.