Senior Software PM – Medical Devices, Agile & Compliance

ECI; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

ECI is seeking a Senior Project Manager to lead Manufacturing Software and SFMD software workstreams within a medical device integration program in Irvine, CA. You will coordinate internal teams and supplier partners to align deliverables, risks, documentation, and execution plans.

The role requires hands-on Jira proficiency, Agile/Scrum experience, and the ability to drive software planning, validation, and release activities in a regulated environment.

Qualifications

• Minimum 5 years of PM experience in regulated medical devices.
• Experience managing software development and manufacturing software.
• Experience with cross-functional teams and suppliers.
• Knowledge of medical device software lifecycle, design controls, validation.
• Proficient in Jira, Confluence; Agile/Scrum practices.
• Certified Scrum Master preferred.

Responsibilities

• Lead planning and execution of the non-product software workstream for product integration.
• Develop integrated project plans, milestones, risks, and release plans.
• Prepare concise status updates and leadership summaries.
• Coordinate internal and supplier-facing activities across stakeholders.
• Manage requirements, validation, release readiness, and production handoffs.
• Foster alignment on design controls, change control, and cybersecurity.
• Maintain Jira metrics and dashboards for program reporting.
• Support agile planning, backlog refinement, and sprint reviews.

Skills

Jira

Confluence

Agile/Scrum planning

Risk management

Stakeholder management

Cross-functional leadership

Independent work

Regulated environments

Education

Bachelor's degree in Engineering/CS

Tools

Jira

Confluence

Job description

ECI is seeking a Senior Project Manager to lead Manufacturing Software and SFMD software workstreams within a medical device integration program in Irvine, CA. You will coordinate internal teams and supplier partners to align deliverables, risks, documentation, and execution plans.

The role requires hands-on Jira proficiency, Agile/Scrum experience, and the ability to drive software planning, validation, and release activities in a regulated environment.