Senior Medical Device Software PM — Agile, Jira Expert

Theuniversityunion; Marlborough (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

ECI in Marlborough, MA seeks a senior project/program manager to lead and coordinate software-related workstreams inside a regulated medical device environment. You will align internal teams with SFMD supplier partners to ensure software activities meet quality system requirements and lifecycle standards.

You will drive planning, risk management, and release readiness while partnering with software engineering, manufacturing, quality, regulatory, and IT teams to deliver compliant, on-time

Qualifications

• PM with 5+ years in the regulated medical device industry.
• Experience managing software development projects in compliance-driven environments.
• Experience working with cross-functional teams and external suppliers.
• Strong knowledge of medical device software lifecycle processes and change control.
• Proficiency with Jira, Confluence, Agile/Scrum planning, dashboards, and metrics reporting.

Responsibilities

• Lead planning and execution of non-product software workstreams across Manufacturing Software and SFMD activities.
• Develop and maintain integrated project plans, milestones, and risks; manage release plans.
• Prepare concise status updates and leadership summaries for risk resolution.
• Coordinate activities across software, manufacturing, quality, regulatory, operations, cybersecurity, IT, and supply chain stakeholders.
• Facilitate design reviews, validation readiness reviews, risk reviews, and audit readiness discussions.
• Track documentation deliverables required for software release and production readiness.

Skills

Project management

Software project management

Stakeholder management

Regulatory compliance

Cybersecurity for medical devices

Manufacturing software

M&A integrations

Supplier management

Agile/ Scrum facilitation

Education

Bachelor's degree in Engineering or related field

Certified Scrum Master

Tools

Jira

Confluence

Jira Advanced Roadmaps

Job description

ECI in Marlborough, MA seeks a senior project/program manager to lead and coordinate software-related workstreams inside a regulated medical device environment. You will align internal teams with SFMD supplier partners to ensure software activities meet quality system requirements and lifecycle standards.

You will drive planning, risk management, and release readiness while partnering with software engineering, manufacturing, quality, regulatory, and IT teams to deliver compliant, on-time