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Job Description
General Function
The objective of the New Product Introduction (NPI) team is to plan and deliver new products in
accordance with the specifications, volume, cost, and timeline agreed upon with the customer.
This role is essential in ensuring that products are available to meet customer needs. The ideal
candidate will have a strong background in project management, supply chain engagement, electro
and mechanical engineering with exceptional leadership skills, and a proven ability to drive crossfunctional
collaboration.
In this role, you will focus on balancing customer requirements with cost efficiency, cash flow and
resources management, ensuring that we meet customer expectations without compromising our
business objectives. Building strong relationships with internal and external stakeholders will be key
to your success, allowing for effective communication and collaboration in addressing customer
needs and driving the business forward.
Duties & Responsibilities
The Project Manager is responsible for the end-to-end planning, execution, and delivery of crossfunctional
projects within the medical technology sector. These may include new product
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:
. Lead cross-functional teams (engineering, quality, regulatory, manufacturing, supply chain,
marketing, etc.) to deliver new medical devices from concept to commercialization.
. Develop and manage detailed project plans, timelines, budgets, and risk registers.
. Drive execution through all phases of the product development lifecycle (PDP/NPD),
including design transfer and production ramp-up.
. Ensure compliance with ISO 13485, FDA QSR, EU MDR, and other relevant
standards/regulations.
. 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:
. 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.
. 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.
. 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.
. 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.
. Technology & Systems: Leverage MS-Project or any other technology to drive data-based
decisions, visibility, and automation across the business
. Leadership & Development: Build and mentor a high-performing project management
team, fostering a culture of continuous improvement and operational excellence.
. 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.
More Info
Key Skills
Product Lifecycle Management (PLM)
Sustainability Compliance
FDA QSR
MS-Project
EU MDR
Manufacturing Transfers

