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4 дня назад

Sr. Manager, Systems and Simulation Engineering (Medical Devices)

190 000 - 215 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr. Manager, Systems and Simulation Engineering (Medical Devices): Leading systems and simulation engineering for regulated medical device development with an accent on system architecture, MBSE, requirements traceability, integration, and verification and validation. Focus on developing validated computational models, managing system-level risks under ISO 14971, and resolving complex technical issues across mechanical, electrical, software, controls, and disposables engineering.

Location: Hybrid in Wayne, New Jersey, United States

Salary: $190,000–$215,000 per year; target bonus: 25%

Company

hirify.global develops medical products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science institutions.

What you will do

  • Lead Systems Engineering and Simulation Engineering teams supporting new product and technology development programs.
  • Direct system architecture, functional decomposition, interface definition, requirements management, and traceability for complex medical device platforms.
  • Lead MBSE, digital engineering, computational modeling, simulation-driven design, and system integration activities.
  • Oversee system-level risk management, verification, validation, Human Factors, pre-clinical activities, and regulatory documentation.
  • Resolve cross-functional technical issues across mechanical, electrical, software, controls, and disposables engineering disciplines.
  • Recruit, mentor, and develop engineering talent while improving processes, tools, methodologies, and organizational capabilities.

Requirements

  • Bachelor’s degree in engineering, systems engineering, biomedical engineering, mechanical engineering, electrical engineering, computer engineering, or a related technical field; a master’s degree is preferred.
  • 10+ years of progressive engineering experience, including at least 5 years of engineering leadership or people management experience.
  • Experience in systems engineering, product development, system integration, requirements management, risk management, and verification and validation within a regulated industry.
  • Experience with computational modeling, simulation, digital engineering, or model-based development tools, including MBSE, FEA, and requirements management tools.
  • Knowledge of simulation techniques such as multiphysics, fluid dynamics, thermal, structural, and control systems analysis.
  • Experience with FDA, ISO 13485, IEC 60601, IEC 62304, ISO 14971, CE Mark, and other regulated product development requirements.

Nice to have

  • Medical device development experience, particularly in cardiovascular, critical care, or life-support technologies.
  • Master’s degree in a relevant engineering discipline.

Culture & Benefits

  • Health, dental, and vision insurance.
  • 401(k) plan with company match.
  • Paid time off, parental and caregiver leave, and disability benefits.
  • Wellness initiatives, health assistance resources, life insurance, and flexible spending accounts.
  • Commuter benefits and tuition reimbursement.

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