Project Manager (Medical Devices / ISO13485)

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

Job summary

RecruitPedia Pte Ltd is supporting a multinational contract manufacturing client in Singapore in hiring a Project Manager – NPI. You will lead end-to-end projects from concept to commercialisation, coordinating design transfer and production ramp-up.

The role requires 5+ years in PM/NPI within regulated environments, and you will manage plans, budgets and cross-functional teams while ensuring ISO 13485, FDA QSR and EU MDR compliance and data-driven improvement.

Qualifications

• Degree in Engineering, Project Management, Supply Chain Management or related discipline.
• Minimum 5 years of project management or NPI experience, preferably in regulated manufacturing.
• Strong experience managing cross-functional product development and production ramp-up.
• Knowledge of ISO 13485, FDA QSR, EU MDR is advantageous.
• Experience in risk, cost control and scheduling with MS Project.

Responsibilities

• Lead end-to-end NPI and product development projects from concept through design transfer, production ramp-up and commercialisation.
• Develop and manage project plans, schedules, budgets, resources, milestones and risk registers.
• Coordinate cross-functional activities across Engineering, Quality, Regulatory, Manufacturing, Supply Chain and procurement.
• Drive project execution in compliance with ISO 13485, FDA QSR and EU MDR.
• Monitor project cost, quality, delivery and supply chain performance; drive efficiency.
• Ensure project documentation is completed on time.

Skills

NPI

Cross-functional leadership

Regulatory knowledge

MS Project

Project planning

Cost control

Design transfer

Supply chain coordination

Risk management

Education

Engineering or related field

Tools

MS Project

Job description

Our client is a multinational company in the Contract Manufacturing industry. Due to their current expansion plan, they are looking for a Project Manager – New Product Introduction (NPI) to join their Engineer team, in hopes of developing the current high performing team. They are located in the North – easily accessible.

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.

Requirements:

• Degree in Engineering, Project Management, Supply Chain Management or a related discipline.

• Minimum 5 years of project management or NPI experience, preferably within medical devices, healthcare, electronics or a regulated manufacturing environment.

• Strong experience managing cross-functional product development, design transfer, manufacturing transfer or production ramp-up projects.

• Knowledge of ISO 13485, FDA QSR, EU MDR and regulated product development processes will be advantageous.

• Experience in supply chain, supplier management, cost control, risk management and project planning, with proficiency in MS Project or similar project management tools.

We regret that only shortlisted candidates will be notified.