PROJECT MANAGER

The Project Manager is responsible for the end-to-end planning, execution, and delivery of cross-functional projects within the medical technology sector. These may include new product development, internal business-driven manufacturing development, clinical studies, regulatory submissions, manufacturing transfers, or market launches. The Project Manager ensures all project objectives are met on time, within scope, and budget - while maintaining compliance with internal quality systems and regulatory requirements.

. Team inspiration and Leadership:

o Lead cross-functional teams (engineering, quality, regulatory, manufacturing, supply chain, marketing, etc.) to deliver new medical devices from concept to commercialization.

o Develop and manage detailed project plans, timelines, budgets, project trackers and risk registers.

o Drive execution through all phases of the product development lifecycle (PDP/NPD), including design transfer and production ramp-up.

o Ensure compliance with ISO 13485, FDA QSR, EU MDR, and other relevant standards/regulations.

o Lead other team as needed in delegate role or other, as/when needed to ensure continuity of the projects as per business requirements.

. Driving Project Velocity:

o Stakeholder Management:

Collaborate with internal and external stakeholders to define project scope, goals, and deliverables.

Serve as the primary point of contact for project status, timelines, risks, and issues.

Facilitate regular project meetings and executive updates.

o Risk Management:

Implement project and product risk mitigation strategies, including diversification, nearshoring, and sustainability initiatives.

Proactively identify project risks and develop mitigation plans.

Resolve issues and conflicts within the project team or escalate as necessary.

o Documentation & Reporting:

Ensure all project documentation, including DMR (Design Master Records), is completed accurately and on time.

Provide regular reports to senior management and participate in design reviews and stage-gate meetings.

o Operational Excellence:

Ensure successful initial implementation of projects into production, including activities related to sourcing, supplier management, planning, logistics, inventory control, and distribution.

Monitor production and supply chain performance, and implement corrective actions as needed to address disruptions, bottlenecks, or inefficiencies.

Identify opportunities for improvement in cost, quality, and delivery speed in collaboration with the Product Lifecycle Management (PLM) Team.

o Technology & Systems: Leverage MS-Project or any other technology to drive data-based decisions, visibility, and automation across the business

o Leadership & Development:Build and mentor a high-performing project management team, fostering a culture of continuous improvement and operational excellence.

o Sustainability & Compliance:Ensure adherence to global trade compliance, regulatory standards, and corporate sustainability goals.

. Change Management Proficiency: Navigate organizational change and evolution, embedding new operating models while ensuring effective team buy-in.