Senior NPI Project Manager, Medical Devices

RecruitPedia Pte Ltd; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is seeking a Project Manager – New Product Introduction (NPI) to lead end-to-end medical device projects from concept to production ramp-up and market launch.

The role is based in Singapore, reporting to the Engineering team within a global organization. You will develop project plans, manage budgets, coordinate cross-functional teams across Engineering, Quality, Regulatory and Manufacturing, and ensure compliance with ISO 13485, FDA QSR and EU MDR while driving efficiency

Qualifications

• Degree in Engineering or related discipline
• Minimum 5 years of project management or NPI experience in regulated manufacturing
• Knowledge of ISO 13485, FDA QSR, EU MDR advantageous
• Experience with MS Project or similar PM tools

Responsibilities

• Lead end-to-end NPI and product development projects from initial concept through design transfer, production ramp-up and commercialisation
• Develop and manage project plans, schedules, budgets, resources, milestones and risk registers to ensure timely and cost-effective delivery
• Coordinate cross-functional activities across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement and other relevant functions
• Drive project execution in accordance with applicable quality systems and regulatory requirements, including ISO 13485, FDA requirements and EU MDR
• Manage stakeholder communication, project meetings, status updates, stage-gate reviews and escalation of key issues
• Identify project risks, supply chain disruptions, production bottlenecks and resource constraints, and implement appropriate mitigation plans
• Oversee design transfer and initial production implementation, including sourcing, supplier management, planning, logistics, inventory and distribution activities
• Monitor project cost, quality, delivery and supply chain performance, identifying opportunities to improve efficiency and project velocity
• Ensure project documentation and records are completed accurately and within required timelines
• Support product lifecycle management, change management, sustainability initiatives and global trade compliance requirements
• Utilise project management systems such as MS Project and other digital tools to improve project visibility, reporting and data-driven decision-making
• Provide leadership and guidance to project team members while supporting continuous improvement and operational excellence

Skills

MS Project

Cross-functional coordination

Regulatory knowledge

Education

Engineering degree

Tools

MS Project

Job description

RECRUITPEDIA PTE. LTD. is seeking a Project Manager – New Product Introduction (NPI) to lead end-to-end medical device projects from concept to production ramp-up and market launch.

The role is based in Singapore, reporting to the Engineering team within a global organization. You will develop project plans, manage budgets, coordinate cross-functional teams across Engineering, Quality, Regulatory and Manufacturing, and ensure compliance with ISO 13485, FDA QSR and EU MDR while driving efficiency