Senior Medical Device Software Program Manager

Theuniversityunion

Arden Hills (MN)

On-site

USD 110,000 - 150,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

ECI seeks a Senior Software Project Manager for a medical device integration program in Minnesota. You will lead software workstreams across manufacturing software, supplier software, and regulatory alignment, coordinating with engineering, quality, IT, and supply chain teams to ensure compliance and on-time delivery.

The role requires hands-on Jira, Agile/Scrum execution, and experience delivering software projects in regulated environments.

Qualifications

Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
5+ years of project or program management experience in the regulated medical device industry.
Demonstrated experience managing software development, manufacturing software, non-product software, or supplier-managed software projects in compliance-driven environments.
Experience with internal cross-functional teams and external suppliers, including SFMD suppliers, contract manufacturers, or supplier software development organizations.
Strong knowledge of medical device software lifecycle processes, design controls, validation, release management, risk management, and change control.
Proficiency with Jira, Confluence, Agile/Scrum planning, backlog management, sprint execution, dashboards, and metrics reporting.
Strong facilitation, dependency management, risk management, communication, and stakeholder management skills.

Responsibilities

Lead planning and execution of the Non-Product Software workstream across Manufacturing Software and SFMD software activities to support product integration and new product development efforts.
Develop and maintain integrated project plans, milestone schedules, and project risks, and release plans.
Prepare concise status updates, leadership summaries, decision logs, and escalation materials for risk and issue resolution.
Coordinate internal and supplier-facing activities across software, manufacturing, quality, regulatory, operations, cybersecurity, IT, and supply chain stakeholders.
Coordinate requirements, design inputs, validation planning, test evidence, release readiness, deployment planning, and production support handoffs.
Partner with Manufacturing Engineering, Operations, Quality, Regulatory, and R&D to ensure internal software solutions meet business, production, and compliance needs.
Facilitate alignment between supplier deliverables and internal expectations for design controls, change control, validation, cybersecurity, risk management, and regulatory readiness.
Identify, track, and elevate dependencies between internal manufacturing systems, supplier-owned software solutions, product configuration, software distribution, and production release activities.
Ensure software project activities are planned and executed in alignment with regulated medical device software lifecycle expectations.
Support software planning, requirements management, verification, validation, traceability, risk management, change management, and release processes.
Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and audit-readiness discussions.
Track objective evidence and documentation deliverables required for software release, manufacturing implementation, medical device manufacturing integration, and sustainment transition.
Participate in agile planning activities, including backlog refinement, sprint planning, daily/weekly team synchronization, sprint reviews, retrospectives, and release planning.
Maintain Jira metrics and dashboard for program-level reporting.
Partner with other project managers, leads, and functional stakeholders to clarify priorities and remove blockers.
Drive continuous improvement in Agile operating cadence, team accountability, and delivery predictability