Software Project Manager / Scrum Master Consultant- Medical Device #3066

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 / Scrum Master Consultant will lead Agile execution and project management of software-related integration activities supporting implantable Class III medical device products within a regulated medical device environment.

This individual will serve as both a project leader and Agile facilitator and coach, driving planning, execution, team alignment, and delivery across cross-functional software initiatives supporting manufacturing operations, software distribution, validation, release management, and production readiness activities.

The ideal contractor/candidate will have demonstrated experience serving as a Scrum Master and/or Agile Project Manager within a medical device company, guiding software teams through regulated development lifecycles while ensuring compliance with quality system requirements, design controls, risk management processes, and software lifecycle standards.

This role requires a strong ability to facilitate Agile ceremonies, remove execution barriers, manage dependencies, and drive predictable delivery across internal teams and external supplier organizations.

What You'll Do

Agile & Scrum Project Leadership

•            Serve as Scrum Master for software teams operating within a regulated medical device environment using JIRA/confluence tool set

•            Facilitate Sprint Planning, Daily Scrums, Backlog Refinement, Sprint Reviews, Retrospectives, and Release Planning

•            Partner with software program manager and functional leaders to prioritize work, manage backlogs, and remove delivery impediments

•            Drive Agile best practices, team accountability, continuous improvement, and predictable delivery

•            Maintain Jira dashboards, metrics, reporting, and portfolio-level visibility

•            Coordinate with software program manager on key risks, issues, dependency tracking, and executive status reporting

Software Lifecycle & Compliance

•            Ensure software activities are executed in accordance with medical device quality system requirements and software lifecycle processes

•            Support requirements management, verification and validation, traceability, risk management, change control, and release activities

•            Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and release approval discussions

•            Track documentation, objective evidence, and compliance deliverables required for software releases and manufacturing implementation

•            Support compliance with applicable standards and regulations, including design controls and software lifecycle requirements

What you will bring

•            5+ years of Project Management, Program Management, Scrum Master, or Agile leadership experience within the medical device industry

•            Advanced proficiency with Jira, Confluence, Agile metrics, backlog management, sprint execution, dashboard development, and reporting

•            Strong communication, facilitation, dependency management, and stakeholder management skills

•            Experience supporting implantable medical devices, neuromodulation systems, cardiac rhythm management product, or other Class III devices

•            Demonstrated experience serving as a Scrum Master for software development, manufacturing software, or software integration teams

•            Strong understanding of medical device software lifecycle processes, including design controls, requirements management, verification and validation, traceability, risk management, change control, and software release management

•            Proven ability to facilitate cross-functional teams, remove impediments, manage risks and dependencies, and drive delivery of complex software initiatives

•            Experience with IEC 62304, ISO 14971, ISO 13485, and FDA medical device quality systems

•            Bachelor’s degree in engineering, Computer Science, Biomedical Engineering, Software Engineering, or related technical discipline

Preferred Qualifications

•            Certified Scrum Master (CSM), Professional Scrum Master (PSM), SAFe Scrum Master, or equivalent Agile certification

•            Experience with acquisitions, product integrations, supplier transitions, or quality system harmonization

•            Experience leading Agile transformation, Agile coaching, or Scrum adoption efforts in regulated software organizations

•            Familiarity with medical device cybersecurity requirements, software risk management, and supplier-managed software development

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.