Project Manager (NPD, ISO13485, Plastic mold) - VTTO

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

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.

EA License No: 19C9682

EA Personnel No: R22104769

EA Personnel Name: Ong Boon Kiet (Travys)