Sr Project Manager - Medical Device #9666

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 Project Manager is responsible for leading and coordinating cross-functional projects throughout the product lifecycle within a regulated medical device environment. This role oversees project planning, execution, resource management, risk mitigation, and stakeholder communication to ensure projects are delivered on time, within scope, and in compliance with applicable quality and regulatory requirements.

What you'll do

• Lead and manage medical device projects from initiation through completion, ensuring alignment with business objectives, timelines, and budgets.

• Develop and maintain project plans, schedules, resource allocations, and risk management strategies.

• Coordinate cross-functional teams including Engineering, Quality Assurance, Regulatory Affairs, Manufacturing, and Operations.

• Monitor project progress, identify risks and issues, and implement mitigation plans to ensure successful project delivery.

• Facilitate project meetings, communicate status updates, and provide regular reporting to stakeholders and senior leadership.

• Ensure project activities comply with applicable regulatory requirements and quality management system procedures, including FDA and ISO 13485 standards.

• Manage project documentation, change controls, and project deliverables throughout the product lifecycle.

• Support new product development, design transfer, process improvement, and remediation initiatives.

• Drive continuous improvement efforts to enhance project execution, efficiency, and organizational effectiveness.

What you will bring

• Bachelor’s degree in Engineering, Life Sciences, or a related field.

• 8 years of experience with at least 6+ years of project management experience, preferably within the medical device, pharmaceutical, biotechnology, or regulated healthcare industry.

• Strong knowledge of medical device development processes and regulatory requirements, including FDA regulations, ISO 13485, and risk management principles.

• Proven ability to lead cross-functional teams and manage multiple projects simultaneously.

• Experience with project management methodologies and tools such as Agile, Waterfall, Microsoft Project, Jira, or similar platforms.

• Excellent organizational, communication, and stakeholder management skills.

• Strong analytical and problem-solving abilities with a proactive and results-oriented mindset.

• PMP certification or equivalent project management certification is preferred.

• Advanced English communication skills, both written and verbal.

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.

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