Senior Software PM - Regulated Medical Devices (Agile/Jira)

MassMEDIC; Marlborough (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

ECI seeks a Senior Software Project Manager to oversee manufacturing software and SFMD software workstreams in a medical device integration program. You will coordinate with cross-functional teams, manage risks, and ensure regulatory compliance throughout software lifecycles.

The role emphasizes Agile/Scrum execution, Jira proficiency, and collaboration with internal and supplier partners to deliver software on schedule and within quality standards.

Qualifications

• 5+ years of project or program management in regulated medical device environments.
• Experience managing software development or supplier-managed software projects.
• Strong knowledge of medical device software lifecycles, design controls, and change control.

Responsibilities

• Lead planning and execution of the non-product software workstream across Manufacturing Software and SFMD software activities.
• Develop 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.
• Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and audit-readiness discussions.

Skills

Agile planning

Backlog management

Risk management

Stakeholder management

Facilitation

Education

Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline

Tools

Jira

Confluence

Jira Advanced Roadmaps

Job description

ECI seeks a Senior Software Project Manager to oversee manufacturing software and SFMD software workstreams in a medical device integration program. You will coordinate with cross-functional teams, manage risks, and ensure regulatory compliance throughout software lifecycles.

The role emphasizes Agile/Scrum execution, Jira proficiency, and collaboration with internal and supplier partners to deliver software on schedule and within quality standards.