2 дня назад
Software Project Manager (Medtech)
135 000 - 180 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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