statistical analysismechanical engineeringiso 13485test developmentcreomechatronicsminitabmedical deviceswindchillmeasurement system analysis
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Роль описана понятно и включает практическую работу над верификацией медицинских устройств, но постоянная работа на площадке и консалтинговый формат могут ограничить гибкость и долгосрочную работу над одним продуктом.
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Проектный форматМедицинские технологииПонятные задачиРабота на площадке
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Текст:
Hirify AI/Оригинал
TL;DR
Consultant Test and Verification (F/M/X) (Mechanical Testing/Medical Devices): Developing and executing verification methods for mechanical and electronic devices, including prototype testing, measurement, data analysis, and technical documentation with an accent on test method validation, measurement system analysis, and medical device requirements. Focus on designing reproducible tests, analysing root causes, and supporting reliable product development from test concept through continuous improvement.
Location: Drachten, Netherlands; permanent onsite role involving work in a mechanical test laboratory.
Company
hirify.global is an independent technology consulting firm providing engineering and life sciences solutions through an international team across more than 60 countries.
What you will do
Develop, validate, execute, and maintain reproducible functional and non-functional test methods for components, subsystems, and integrated products.
Define test concepts and coordinate test activities while considering feasibility, cost, timing, quality, and equipment constraints.
Support engineering concept development and prototype realization within multidisciplinary product development teams.
Plan, perform, coordinate, and report tests and measurements, including measurement system analysis and statistical data analysis.
Lead or support root cause analysis, problem-solving, continuous improvement, and technical knowledge-base development.
Maintain test areas and equipment, provide technical support, and share laboratory and test-method knowledge.
Requirements
Bachelor’s or Master’s degree in mechanical engineering, mechatronics, physics, or a related technical discipline.
At least 2 years of experience in research and development, test development, mechanical engineering, or a comparable technical environment, plus at least 3 years of experience in a mechanical test laboratory.
Experience designing, documenting, and executing test methods, with a solid understanding of design verification and product development processes.
Knowledge of measurement system analysis, test method validation, and statistical data analysis.
Experience writing clear and accurate technical documentation according to internal procedures and applicable standards.
Knowledge of medical device development and testing requirements, including ISO 13485, 21 CFR Part 820, and Good Documentation Practices.
Practical experience with Windchill and Minitab.
Understanding of mechanical construction in plastic and metal, including mass-manufacturing considerations such as mould and assembly tooling.
Strong analytical, communication, and problem-solving skills; a hands-on, independent, and collaborative working style; and the ability to manage or delegate tasks when required.
Nice to have
Experience with 3D CAD software, preferably Creo.
Culture & Benefits
Inclusive and diverse equal-opportunity workplace.
Work in a high-tech innovation environment with multidisciplinary product development teams.
Opportunities to contribute across the full product development lifecycle and develop technical expertise.
Hiring process
Brief virtual or phone call.
Approximately three interviews on average, with the number varying by seniority.
Role-dependent case study, technical assessment, role play, or problem-solving scenario.
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