Senior Medical Device Software Project Lead

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

Job summary

ECI seeks a capable project/program manager to oversee Manufacturing Software and SFMD software workstreams within a medical device integration program. You will partner with cross-functional teams to align deliverables, dependencies, risks, and plans, ensuring compliance with medical device quality systems.

The role requires strong Jira/Agile discipline, experience in regulated environments, and the ability to drive planning, validation, and release activities across manufacturing, regulatory,

Qualifications

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
• 5 or more years of project or program management experience in the regulated medical device industry.
• Experience managing software development, manufacturing software, non-product software, or supplier-managed software projects in compliance-driven environments.
• Experience working with internal cross-functional teams and external suppliers, including SFMD suppliers, contract manufacturers, or supplier software development organizations.
• Strong working knowledge of medical device software lifecycle processes, design controls, validation, release management, risk management, and change control.
• Required proficiency with Jira, Confluence, Agile/Scrum planning practices, backlog management, sprint execution, dashboards, and metrics reporting.
• Strong facilitation, dependency management, risk management, communication, and stakeholder management skills.
• Ability to operate independently, drive clarity in ambiguous environments, and escalating risks with clear options and recommendations.
• Certified Scrum Master or equivalent Scrum Master training or experience.
• Experience supporting acquisitions, product integrations, supplier transitions, or quality system harmonization activities.
• Experience with manufacturing systems, software distribution, configuration management.
• Experience with Jira Advanced Roadmaps, portfolio reporting, Agile metrics, and executive-level dashboarding.
• Familiarity with cybersecurity requirements for connected medical devices, manufacturing software, or supplier-managed software environments.

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-facings 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 escalation 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

Skills

Jira

Confluence

Agile/Scrum planning

Backlog management

Dashboards & metrics reporting

Stakeholder management

Risk management

Change control & validation

Education

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

Tools

Jira Advanced Roadmaps

Portfolio reporting tools

Job description

ECI seeks a capable project/program manager to oversee Manufacturing Software and SFMD software workstreams within a medical device integration program. You will partner with cross-functional teams to align deliverables, dependencies, risks, and plans, ensuring compliance with medical device quality systems.

The role requires strong Jira/Agile discipline, experience in regulated environments, and the ability to drive planning, validation, and release activities across manufacturing, regulatory,