Project Manager / Senior Engineer (Medical Devices / ISO13485)

RecruitPedia Pte Ltd; Hong Kong; On-site; HKD 550,000 - 900,000; Full time

Job summary

RecruitPedia Pte Ltd's client, a multinational Contract Manufacturing company, is seeking a Project Manager for New Product Introduction (NPI) to lead end-to-end product development from concept to commercialisation. You will work with cross-functional teams across Engineering, Quality, Regulatory, and Manufacturing in a regulated environment.

The role focuses on developing plans, managing budgets, schedules and risks, ensuring ISO 13485, FDA QSR and EU MDR compliance, and driving design and

Qualifications

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

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

Project management

NPI

Cross-functional leadership

MS Project

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.