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12 дней назад

Principal Systems Engineer (CAS)

134 400 - 201 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Ireland
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
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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