requirements managementrisk managementsystem architecturecybersecuritysystems engineeringmedical devicesverification and validationcardiac ablation
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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$134к-202к/год
$130к$150кмедиана$180к
По похожим ролям (50) ~ $150к/год
На СНГ рынке: $2.5к/мес ($1.9к - $3.1к)
90
Крутая вакансия
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Чётко очерченная ведущая роль в крупной medtech-компании предполагает заметное техническое лидерство на всех этапах жизненного цикла продукта, хотя обязательное присутствие в офисе четыре дня в неделю снижает гибкость.
Четыре дня в офисе
Чёткая зона ответственности
Влияние на здравоохранение
Техническое лидерство
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Principal Systems Engineer (CAS) (Medical Devices/Cardiac Ablation): Leading systems engineering for cardiac mapping and ablation technologies across architecture, requirements, risk management, verification, validation, and the full product lifecycle with an accent on multidisciplinary medical-device integration and patient-safety-critical design. Focus on defining system architectures and interfaces, resolving complex system-level issues, establishing verification and validation strategies, and influencing technical decisions across global teams.
Location: Onsite in Mounds View, Minnesota, United States, with Galway, County Galway, Ireland also listed as a location; onsite work 4 days per week and less than 10% travel required.
Base salary: USD 134,400–201,600 in the United States; EUR 81,120–121,680 in Ireland. The role is also eligible for a short-term incentive plan.
Company
hirify.global develops healthcare technologies, including cardiac mapping and ablation products, to alleviate pain, restore health, and extend life.
What you will do
Lead systems engineering for complex, multidisciplinary cardiac ablation medical-device programs and significant product changes across the full product lifecycle.
Translate customer, clinical, use-case, and use-environment needs into system-level design inputs and requirements.
Define system architecture, functional decomposition, interfaces, operating modes, performance budgets, and design trade-offs across hardware, software, firmware, disposables, and accessories.
Lead requirements lifecycle management, risk integration, system verification and validation strategies, technical reviews, and anomaly resolution.
Direct cross-functional root-cause investigations and system-level troubleshooting across design, integration, manufacturing, suppliers, field performance, and product quality.
Mentor systems engineers, influence global teams without direct authority, and support regulatory submissions, CAPA, product changes, and post-market improvements.
Requirements
Bachelor’s degree in Engineering, Physics, or a related degree program.
At least 7 years of relevant experience, or a Master’s degree with at least 5 years of relevant experience, or a PhD with 3 years of relevant experience.
For baccalaureate degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice to have
Medical-device or highly regulated industry experience, including design controls and product lifecycle processes.
Experience with cardiac electrophysiology, cardiac mapping, ablation energy delivery, therapeutic catheters, sheaths, generators, navigation or visualization systems, or related accessories.
Knowledge of medical-device risk management, usability engineering, software lifecycle, electrical medical equipment, cybersecurity, and quality-system expectations.
Experience with Polarion, Jama Connect, IBM Engineering Requirements Management DOORS, or equivalent requirements and application-lifecycle tools.
Experience with model-based systems engineering, SysML, architecture frameworks, simulation, or system modeling tools.
Experience with Design for Reliability and Manufacturability, statistical methods, test method development, root-cause analysis, and structured problem solving.
Experience supporting regulatory submissions, agency or notified-body interactions, audits, CAPA, complaint investigations, or field corrective actions.
Mentoring, coaching, and technical-community leadership across global or distributed teams.
Culture & Benefits
Onsite collaboration is expected 4 days per week, with less than 10% travel.
Regular employees may receive health, dental, vision, life, disability, retirement, paid time off, paid holidays, tuition assistance, and employee stock purchase benefits, subject to eligibility and location.
The role includes a short-term hirify.global Incentive Plan.
U.S. work authorization sponsorship is offered for Principal-level roles and above where specialized expertise aligns with long-term business needs.
Hiring process
Applicants should ensure that the minimum education and relevant-experience requirements are evident in their applicant profile.
Applications must be submitted through official hirify.global channels.
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