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Principal Systems Engineer (Medical Devices)

170 000 - 190 000$
Формат работы
onsite
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
Principal Systems Engineer (Medical Devices): Defining, architecting, and technically managing the product realization process for cardiac and respiratory medical devices with an accent on system requirements, cross-functional engineering leadership, and FDA-regulated product development. Focus on translating patient and stakeholder needs into system architectures, investigating technical risks, and supporting verification, reliability testing, FMECA analysis, and risk management.

Location: Pittsburgh, PA; onsite at ZOLL Cardiac Management Solutions offices. Evening and weekend work may occasionally be required.

Annual salary: $170,000–$190,000.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including LifeVest, HFMS, and TherOx technologies.

What you will do

  • Collaborate with New Product Planning, Product Management, Medical Affairs, Regulatory Affairs, Human Factors, and other stakeholders to identify and prioritize patient and stakeholder needs from concept through design output.
  • Translate market requirements and identified needs into system-level and detailed engineering requirements, and drive cross-functional approval.
  • Lead system architecture definition and collaborate with engineering teams to refine the architecture.
  • Drive technical investigations addressing architectural uncertainties, requirement unknowns, and technical risk areas.
  • Support test-case generation for system-level and detailed requirements, engineering verification, reliability testing, FMECA analysis, and product risk management.
  • Collaborate with engineering managers and technical program managers to identify resource needs and lead major multifunctional engineering activities throughout the product development life cycle.

Requirements

  • B.S. or M.S. degree, or equivalent industry experience, in engineering or a related discipline.
  • At least 10 years of product development experience.
  • Proven track record performing the relevant systems engineering duties and responsibilities.
  • Demonstrated ability to plan, direct, and conduct engineering research and development activities.
  • Strong conflict resolution, analytical, and decision-making skills.
  • Strong verbal and written communication skills.
  • Ability to regularly sit, talk, and hear; occasionally stand and walk; and occasionally lift or move up to 25 pounds.

Nice to have

  • 15+ years of industry experience with FDA-regulated devices.

Culture & Benefits

  • Work on technologies intended to improve outcomes for patients with critical cardiopulmonary conditions.
  • Culture emphasizing innovation, self-motivation, and entrepreneurial spirit.
  • Comprehensive benefits plans are available.
  • ZOLL operates in more than 140 countries.

Hiring process

  • Applications are accepted on an ongoing basis until the position is filled.

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