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2 дня назад

Software Project Manager (Medtech)

135 000 - 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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Описание вакансии

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TL;DR
Software Project Manager (Medtech): Leading planning, coordination, and execution of software development programs and releases for the Edison histotripsy system with an accent on FDA-regulated medical device development, cross-functional alignment, and release readiness. Focus on coordinating requirements, verification, validation, DHF documentation, traceability, and audit-ready delivery across engineering, quality, regulatory, product, clinical, and systems teams.

Location: Hybrid role based in Plymouth, MN or Ann Arbor, MI, US; up to 10% domestic travel required.

Salary: $135,000–$180,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive histotripsy therapy platform for liver tumors and future applications across multiple disease areas.

What you will do

  • Lead software project execution across feasibility, development, verification, validation, and release activities.
  • Coordinate software release scope, priorities, dependencies, risks, milestones, and readiness across engineering, quality, regulatory, product, clinical, and systems teams.
  • Facilitate release planning, quarterly planning, scrum of scrums, risk reviews, milestone reviews, and other Agile ceremonies.
  • Plan and track release documentation and Design History File deliverables, ensuring completeness, traceability, and audit readiness.
  • Maintain project and release dashboards with metrics covering scope, progress, risks, and release readiness.
  • Communicate project status and constraints to stakeholders and Product Development Leadership while driving alignment without direct authority.

Requirements

  • Bachelor’s degree or equivalent experience in a technical, engineering, scientific, business, or related field.
  • 10+ years of experience in software project management, software program management, or related software development roles.
  • At least 3 years supporting FDA-regulated medical device software product development.
  • Experience coordinating complex software releases, requirements management, verification, defect management, design reviews, and regulatory deliverables.
  • Experience with IEC 62304, Design Controls, Design History File deliverables, traceability, and audit readiness.
  • Experience using Azure DevOps or similar tools; U.S. work authorization is required and visa sponsorship is not available.

Nice to have

  • Certified Scrum Master, PMI-ACP, or equivalent Agile certification.

Culture & Benefits

  • Full-time employment with health, dental, and vision insurance.
  • Life, short-term disability, and long-term disability insurance.
  • 401(k), paid time off, and additional benefits.
  • Work in a cross-functional medtech environment combining advanced science with clinical application.

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