Software Project Manager- Medical Devices #5894 Full Time NEW

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 Software Project Manager is responsible for planning, executing, and delivering software development projects that support regulated medical device products. This role partners closely with ECI’s clients Software Engineering, Quality, Regulatory Affairs, Clinical, and Product Management to ensure projects are delivered on time, within scope, and in compliance with applicable regulatory and quality standards (e.g., FDA, ISO 13485, IEC 62304). The ideal candidate combines strong project management expertise with a solid understanding of software development lifecycles in a regulated medical device environment. This is a remote role with travel as needed up to 25%.

What You Will Do

• Project Planning & Execution
• Lead cross-functional software development projects from initiation through commercialization and post-market support
• Develop and maintain detailed project plans, schedules, budgets, and resource forecasts
• Define project scope, deliverables, milestones, and success criteria
• Track and report project status, risks, dependencies, and mitigation plans to stakeholders
• Agile & SDLC Management
• Manage projects using Agile, hybrid, or waterfall methodologies as appropriate
• Facilitate sprint planning, daily stand-ups, backlog grooming, sprint reviews, and retrospectives
• Ensure alignment between product requirements, software design, implementation, testing, and release

Regulatory & Quality Compliance

• Ensure software development activities comply with regulatory and quality standards, including:
• FDA 21 CFR Part 820
• ISO 13485
• IEC 62304 (Software Lifecycle Processes)
• ISO 14971 (Risk Management)
• Support documentation development, reviews, and approvals (e.g., requirements, design, risk analyses, verification/validation)
• Partner with Quality and Regulatory teams during audits, inspections, and submissions

Stakeholder Collaboration

• Serve as the primary point of contact for software project status and communications
• Coordinate activities across Engineering, QA/RA, Product Management, Clinical, Manufacturing, and external vendors
• Manage expectations and resolve conflicts to keep projects on track

Risk & Change Management

• Identify project risks and develop mitigation strategies
• Manage scope changes through formal change control processes
• Proactively address issues impacting quality, timeline, or compliance

What You Will Bring

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

7+ years of project management experience in medical devices

2+ years of medical device software project management

5+ years of experience in the medical device, healthcare, or other regulated industry

Strong knowledge of software development lifecycles (Agile, Waterfall, Hybrid)

Demonstrated experience working with cross-functional and global teams

Excellent communication, organization, and problem-solving skills

Preferred Qualifications

• Experience managing software projects for SaMD (Software as a Medical Device) or embedded medical device software
• Familiarity with FDA QSR, ISO 13485, IEC 62304, and ISO 14971
• PMP, PMI-ACP, Scrum Master, or similar project management certification
• Experience with JIRA, Confluence, MS Project, Smartsheet, or similar tools

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.