Are you an experienced engineer who has the ability to steer and coordinate verification related activities? Can you develop verification methods and tools including hands-on execution of tests? And do you want to work in a fast paced and highly dynamic product development environment which focus on development of home-use medical devices? Take a look at this position.
In this role you are responsible for making test and verification plans for (prototype) products in a broad range of home-use medical devices.
You are the right person if:
• 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.
Your key skills to be successful in this role:
• 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).
• 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.
When you are interested in the position, please contact our account manager Jerphaas de Hoogh (– Klik op de solliciteer-button om te solliciteren –). Please send a motivation letter in english with your application.