Senior Engineer Test and Verification,
We are looking for an experienced engineer who has the ability to steer and coordinate verification related activities and develop verification methods and tools including hands-on execution of tests. You will work in a fast paced and highly dynamic product development environment which focus on development of home-use medical devices.
Subject matter expertise in the domain of verification (hardware, embedded systems, medical devices).
Deep understanding how verification tools need to be created to comply with regulations e.g. 21CFR 820, ISO13485, ISO10012 (requirement engineer, system design, verification).
Knowledge about methods, tools and related standards used for verification testing (e.g. statistics and lifetime/reliability testing, requirement engineering).
Patient and diligent when it comes to the execution of verification tests.
Communication skills (certainly fluent in English, proficient technical writing skills).
You built already verification tools and successfully defended your documentation in an FDA inspection.
You managed the verification part of 2 or 3 projects, starting supporting the development of requirements and executing the verification program (E2E).
People recognize you as an expert or local though leader in the verification domain.
You come from a similar industry and worked on products such as IPL hair removal devices, facial cleaning brushes, breast pumps, pain therapy devices, wearables.
Review, comment and propose on product requirements to ensure testability and “design for test”.
Give input on test designs regarding feasibility (costs, timing, quality, location).
Establish and maintain verification methods and verification tools.
Execute tests and measurements and analyze market return samples.
Create function related documentation/deliverables including local QMS related documents.
Contribute to functional continuous improvement plan and knowledge base.
Technical background (MSc), preferably mechatronics. Needs certainly an understanding of mechanics, electronics and software to develop verification tools.
8-15 years of experience in the field of test and verification within product development.
Practical, with a strong hands-on mentality, also able to manage and delegate tasks when necessary.
Good project management skills, ability to work in a structured and transparent way by defining working packages, delegating tasks (when necessary), and appropriate status reporting.
Fluent written and verbal English skills as this is the primary language in the office.
Ability to work on multiple projects at the same time.
Quality mindset and comfortable with documentation; understands what an objective evidence is. Quality driven mindset.
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