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8 дней назад

Senior Technical Project Manager, R&D HW/FW (Medical Devices)

138 000 - 180 000$
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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TL;DR
Senior Technical Project Manager, R&D HW/FW (Medical Devices): Leading the planning, execution, and commercialization of complex embedded hardware and firmware medical device products with an accent on design control, cross-functional delivery, and regulatory compliance. Focus on coordinating engineering, quality, manufacturing, and clinical stakeholders, managing project risks, and driving Scrum execution from concept through production.

Location: Hybrid in San Francisco or Cypress, California; Orange County, California. Travel up to 10% for team meetings and offsites.

Estimated pay range: $138,000–$180,000 per year.

Company

hirify.global develops wearable cardiac monitoring solutions that combine biosensors, cloud-based analytics, and proprietary algorithms to improve patient care.

What you will do

  • Lead planning, execution, and delivery of embedded hardware and firmware products from concept through production.
  • Develop project scopes, work breakdown structures, estimates, resource plans, schedules, release plans, and risk registers.
  • Coordinate engineering, product management, quality, regulatory, manufacturing, marketing, clinical operations, and customer support stakeholders.
  • Manage technical documentation for change requests, design changes, project closure, and design control compliance.
  • Act as Scrum Master for sprint planning, backlog refinement, stand-ups, and retrospectives.
  • Support production releases, project health monitoring, and continuous process improvement.

Requirements

  • BS degree in Engineering or a related technical field.
  • 8+ years of professional engineering experience with extensive cross-functional collaboration.
  • 4+ years leading development projects, including design transfer to manufacturing and product commercialization.
  • Strong project management, budgeting, planning, risk management, analytical, organizational, and communication skills.
  • Experience with technical product development teams, embedded systems, and design transfer processes; medical device experience is strongly preferred.
  • Proficiency with Microsoft Office, including Project and Visio; familiarity with Jira and Confluence is beneficial.

Nice to have

  • Master’s degree, MBA, or PMP certification.
  • Experience with IEC 62304, IEC 14971, and IEC 62366 standards.
  • Experience with JAMA requirements management.
  • Proficiency in AWS, Linux, Unix, or Windows environments.

Culture & Benefits

  • Collaborative, fast-paced environment focused on cardiac health innovation.
  • Opportunity to work on medical device projects addressing unmet clinical needs.
  • Exposure to domestic and international product markets.
  • Inclusive workplace welcoming diverse backgrounds, experiences, skills, and perspectives.

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