Senior Project Manager – Medical Devices

About the role

The Senior Project Manager will lead cross‑functional medical device projects from initiation through completion, ensuring alignment with business objectives, timelines, and regulatory requirements. This position operates within a regulated environment, coordinating engineering, quality, regulatory, manufacturing and operations teams to deliver products on schedule and within scope.

Key responsibilities

• Develop and maintain detailed project plans, schedules, resource allocations and risk mitigation strategies.
• Coordinate and lead multidisciplinary teams, including Engineering, Quality Assurance, Regulatory Affairs, Manufacturing and Operations.
• Monitor project progress, identify issues, and implement corrective actions to keep projects on track.
• Facilitate project meetings, provide status updates and regular reporting to senior leadership and stakeholders.
• Ensure compliance with FDA, ISO 13485 and other applicable quality and regulatory standards throughout the product lifecycle.
• Manage project documentation, change controls and deliverables for new product development, design transfer and process improvement initiatives.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or a related field.
• At least 8 years of professional experience, including 6+ years of project management in medical devices, pharmaceuticals, biotechnology or a regulated healthcare environment.
• Strong knowledge of medical device development processes and regulatory requirements (FDA, ISO 13485, risk management).
• Proven ability to lead multiple projects simultaneously and manage cross‑functional teams.

Required skills

• Agile project management methodology.
• Waterfall project management methodology.
• Microsoft Project.
• Jira.