Project Manager – Medical Devices

RecruitPedia Pte Ltd; Hong Kong; On-site; HKD 706,000 - 1,020,000; Full time

Job summary

RecruitPedia Pte Ltd is seeking a proactive Project Manager to own end-to-end planning and execution of medical device projects, collaborating with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain to deliver on time, within scope and budget.

You will lead NPI/NPD, design transfer, production ramp-up and commercialisation, manage budgets and risks, ensure DMR documentation and regulatory compliance, and drive continuous improvement using MS Project.

Qualifications

• Degree in Engineering or related technical discipline.
• 2-3 years PM experience in medical device contract manufacturing.
• At least 3 years leading cross-functional technical teams.
• Experience in NPI/NPD, product development, design transfer and production ramp-up.
• Hands-on with DMR / Design Master Records and PLM.
• Proficient in ISO 13485; FDA QSR and EU MDR knowledge is a plus.
• Good stakeholder management, communication and problem-solving skills.
• Experience managing project risks, timelines, budgets and multiple stakeholders.

Responsibilities

• Lead cross-functional medical device projects from concept, NPI/NPD and design transfer through to production ramp-up and commercialisation.
• Develop and manage project plans, timelines, budgets, risks and deliverables.
• Coordinate Engineering, Quality, Regulatory, Manufacturing, Supply Chain and other teams to drive project execution.
• Manage stakeholder communication, project meetings, status updates, risks and issues.
• Ensure project documentation, including DMR, is completed accurately and on time.
• Ensure projects comply with ISO 13485, FDA QSR, EU MDR and other regulatory requirements.
• Support manufacturing implementation, supplier management, sourcing and production readiness.
• Identify opportunities to improve cost, quality, delivery and operational efficiency.
• Drive risk mitigation, change management and continuous improvement initiatives.
• Use MS Project to provide project visibility and support data-driven decision making.

Skills

Cross-functional leadership

Stakeholder management

Problem-solving

Communication

Risk management

Education

Engineering degree

Tools

MS Project

Job description

About the role

You will take ownership of end-to-end project planning and execution, working closely with Engineering, Quality, Regulatory, Manufacturing, Supply Chain and other stakeholders to ensure projects are delivered on time, within scope and budget.

Key responsibilities

• Lead cross-functional medical device projects from concept, NPI/NPD and design transfer through to production ramp-up and commercialisation.

• Develop and manage project plans, timelines, budgets, risks and deliverables.

• Coordinate Engineering, Quality, Regulatory, Manufacturing, Supply Chain and other teams to drive project execution.

• Manage stakeholder communication, project meetings, status updates, risks and issues.

• Ensure project documentation, including Design Master Records (DMR), is completed accurately and on time.

• Ensure projects comply with ISO 13485, FDA QSR, EU MDR and other relevant regulatory requirements.

• Support manufacturing implementation, supplier management, sourcing, planning and production readiness.

• Identify opportunities to improve cost, quality, delivery and operational efficiency throughout the product lifecycle.

• Drive risk mitigation, change management and continuous improvement initiatives.

• Use project management tools such as MS Project to provide project visibility and support data-driven decision making.

About you

• Degree in Engineering or a related technical discipline.

• Minimum 2-3 years of Project Management experience within medical device contract manufacturing.

• At least 3 years of experience leading cross-functional technical teams.

• Experience in NPI/NPD, product development, design transfer and production ramp-up.

• Hands-on experience with DMR / Design Master Records and Product Lifecycle Management (PLM).

• Proficient in ISO 13485; knowledge in FDA QSR and EU MDR is a plus.

• Good stakeholder management, communication and problem-solving skills.

• Experience managing project risks, timelines, budgets and multiple stakeholders.

About us

Our client is a leading Singapore-based medical device contract manufacturer with operations across Singapore, Malaysia and China.

We regret that only shortlisted candidate will be notified.