requirements managementrisk managementsystems engineeringfmeamedical devicesverification and validationiso 14971requirements traceability
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Роль чётко определена в известной продуктовой medtech-компании и даёт заметную ответственность за системы, влияющие на пациентов; при этом работа в регулируемой отрасли включает серьёзный объём документации и контроля соответствия.
?Строгие процессы
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Влияние на медицину
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Текст:
Hirify AI/Оригинал
TL;DR
Senior Systems Engineer - ACM (Medtech): Developing, integrating, and validating complex physiologic monitoring systems with an accent on requirements engineering, risk management, system-level verification, and end-to-end traceability. Focus on defining test strategies, analyzing system performance and defects, linking hazards to mitigations and verification evidence, and leading cross-disciplinary integration.
Location: Galway, County Galway, Ireland; Flexible Work Arrangement / hybrid
Salary: EUR 64,640–96,960 per year, plus eligibility for the hirify.global Incentive Plan
Company
hirify.global develops healthcare technologies, including non-invasive physiological monitoring solutions for surgery, critical care, and other high-risk clinical settings.
What you will do
Develop, decompose, and maintain testable system and subsystem requirements for physiologic monitoring technologies.
Translate user and clinical needs into system architectures and requirements with cross-functional stakeholders.
Maintain traceability from user needs through design, implementation, verification, and risk controls.
Lead risk management activities, including hazard analysis, FMEA/FMECA, and linkage between risks, mitigations, and verification evidence.
Define system-level test strategies and cases, analyze test data, and resolve integration issues and system-level defects.
Support design reviews, technical documentation, design controls, and provide technical leadership and mentoring across engineering disciplines.
Requirements
Strong systems engineering background with complex electromechanical, software-enabled, or medical device systems.
Experience developing structured requirements using Polarion, Jama, or similar tools, and managing requirements baselines and changes.
Proven ability to maintain traceability between requirements, design elements, test cases, and risk controls.
Hands-on regulated-product risk management experience, including ISO 14971 or equivalent practices, hazard analysis, and failure mode analysis.
Expertise in system-level verification and validation, including test plan development, test execution oversight, and results analysis.
Familiarity with quality systems and design control for medical devices or similarly regulated industries.
Strong analytical, communication, and collaboration skills, with the ability to influence multiple engineering disciplines.
Bachelor’s degree in Engineering or a related technical field.
Nice to have
Advanced degree.
Prior experience with physiologic or patient monitoring systems.
Culture & Benefits
Full-time position with a flexible work arrangement.
Competitive salary and flexible benefits package.
Eligibility for the short-term hirify.global Incentive Plan.
Work within a healthcare technology organization focused on improving patient outcomes.
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