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

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V&V Engineer

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.

Requirements

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


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