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4 дня назад

Prin Hardware System Engineer (Medical Devices)

140 800 - 211 200$
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
Prin Hardware System Engineer (Medical Devices): Developing and integrating electrical hardware systems for regulated medical device products with an accent on system-of-systems architecture, traceability, safety, and clinical requirements. Focus on leading subsystem development, validating products against medical device standards, coordinating cross-functional teams, and delivering portfolio-level integrations including connectivity and AI.

Location: Onsite in Lafayette, Colorado, United States

Salary: $140,800–$211,200 per year

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life.

What you will do

  • Lead collaboration among subsystem owners and align functional design interfaces, timelines, budgets, and technical commitments.
  • Translate product concepts into fully functional and tested medical device systems in collaboration with Product Owners.
  • Define applicable medical device standards and coordinate testing, validation, technical documentation, and traceability.
  • Review schematics, PCBA layouts, component selections, and 3D CAD assemblies within integrated system builds.
  • Coordinate software, mechanical, electrical, manufacturing, and external design partners to deliver integrated products.
  • Track risks and findings, support stage-gate reviews, and contribute to connectivity and AI initiatives through product release and launch.

Requirements

  • 7+ years of experience in medical device systems, digital, or software development.
  • Experience with at least 3 system-level product or portfolio releases.
  • Ability to understand complex system behavior, engineering problems, and constraints across electrical hardware, mechanical systems, software, and integration.
  • Experience documenting technical inputs, design outputs, and traceability in Polarion or similar tools.
  • Knowledge of standards including IEC 60601, ISO 62304, and ANSI C63.27.
  • Unrestricted U.S. work authorization is required for roles below the Principal level; U.S. sponsorship is limited to Principal-level roles and above.

Nice to have

  • Experience with Agile methodology.
  • Experience in a regulated product industry.
  • Strong design portfolio demonstrating previous design work.

Culture & Benefits

  • Full-time onsite work within a global healthcare technology organization.
  • Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
  • 401(k) plan with employer contribution and match, paid time off, and paid holidays.
  • Tuition assistance, employee stock purchase plan, incentive plans, and well-being resources.

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