MedTech Software Project Manager, Edison System Leader

HISTOSONICS INC

Ann Arbor (MI)

On-site

USD 135,000 - 180,000

Full time

11 days ago

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Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Paid time off

Job summary

HistoSonics in Ann Arbor, MI, seeks a Software Project Manager to lead software releases for the Edison system, coordinating across software engineering, QA, regulatory, and product teams to meet milestones and regulatory requirements.

The role requires 10+ years in software or PM in regulated environments, 3+ years in Agile delivery, and certifications such as CSM/PMI-ACP. Domestic travel up to 10% may be required, with a competitive benefits package.

Qualifications

Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field.
10+ years of software engineering or project management experience in a regulated industry; preferably medical devices.
3+ years leading software delivery within Agile development teams.
Experience planning and coordinating complex software releases involving multiple teams, dependencies, and regulatory deliverables.
Certified Scrum Master (CSM, CSP-SM), PMI-ACP, or equivalent Agile certification preferred.
Experience building project dashboards, defining success metrics, and tracking work using Jira, Azure DevOps, or similar tools.
Proven ability to collaborate across matrixed organizations, communicate technical status and risks effectively, and drive alignment without direct authority.
Understanding of phase-gate or milestone-based product development in regulated environments.
Experience supporting FDA-regulated software development and familiarity with IEC 62304.

Responsibilities

Lead software project execution across feasibility, development, verification, validation, and release activities.
Drive cross-functional alignment on scope, priorities, dependencies, and milestones to support successful software delivery.
Coordinate day-to-day execution with a hands-on approach, engaging directly with teams to drive progress, remove blockers, and maintain alignment to sprint and release goals.
Facilitate software project meetings, planning activities, release readiness reviews, and Agile ceremonies as needed.
Coordinate cross-functional teams to ensure alignment on roles, priorities, scope, dependencies, and risks.
Serve as the central point of contact for software projects, providing updates and escalating constraints to Product Development Leadership.
Communicate clearly and proactively with stakeholders, tailoring messaging across technical, clinical, regulatory, and leadership audiences.
Lead release readiness activities and reviews in accordance with the Software Development Process.
Own the planning, tracking, and delivery of all software release documentation and DHF deliverables; ensure completeness, accuracy, and audit readiness across the full release lifecycle.
Build and maintain project and release dashboards, defining and monitoring key metrics to provide real-time visibility into scope, progress, risks, and release readiness.
Apply phase-gate and milestone-driven product development principles to ensure project documentation and processes meet regulatory requirements.