Senior Software Project Manager - Medical Device #3065- Marlborough, MA

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

• Location Marlborough, MA,Marlborough, MA, 01752,United States
• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree
• Travel 20%

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role

The ideal candidate will manage Manufacturing Software and Sourced Finished Medical Device software-related workstreams within a medical device integration program. The role will support internal manufacturing software, supplier-managed software activities, software distribution, validation, release planning, production readiness, and transition-to-sustainment activities. This individual will work directly with internal cross-functional teams and SFMD supplier partners to align deliverables, dependencies, risks, documentation, and execution plans. The contractor will partner with Software Engineering, Manufacturing Engineering, Quality, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, Cybersecurity, IT, and external supplier organizations to ensure software activities are completed in accordance with applicable medical device quality system requirements and software lifecycle standards. The successful candidate must bring strong project management discipline, hands‑on Jira proficiency, Agile/Scrum operating experience, and practical experience delivering software projects in regulated medical device environments.

What You’ll Do

• 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 escalate 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

What you will bring

• 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.
• Demonstrated 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 escalate 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.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.