Project Manager

Forefront Medical Investment Pte Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Forefront Medical Investment Pte Ltd in Singapore seeks an experienced Project Lead for end-to-end management of medical device projects. You will oversee execution, validation, and commercialization, while coordinating assembly processes for new product introductions and ensuring regulatory compliance.

You will coach technical teams, liaise with customers, and drive cross-department collaboration to meet milestones and budgets. Strong leadership and regulatory knowledge are essential.

Qualifications

• Diploma/Bachelor/Masters in Mechanical or Manufacturing Engineering or related disciplines.
• Minimum 6 years of industrial technical experience including project/program management.
• Minimum 4 years of experience in medical device manufacturing in a regulated environment (FDA 21 CFR Part 820 or equivalent).
• Experience with Medical Device Directive (MDD), ISO 13485 and FDA design control.
• Strong knowledge in extrusion, molding and assembly processes used in medical device manufacturing and exposure to sterilization processes.
• Knowledge and experience in process validations.
• Exposure to product development of medical devices.
• Broad knowledge and experience in polymer materials processing.
• Effective leadership with good communication, presentation and problem-solving skills.

Responsibilities

• Overall accountability for execution, validation and commercialization of all projects.
• Lead assembly process setup and process development for new product introduction (NPI).
• Manage project teams to deliver on time and on budget, compliant with standards/regulations.
• Coach and provide technical support to project, process and validation teams.
• Liaise with customers on commercialization of projects.

Skills

Project management

Medical device manufacturing

Regulatory knowledge

Process validation

Leadership

Communication

Education

Diploma/Bachelor/Masters in Mechanical engineering / Manufacturing engineering/ Other engineering disciplines

Job description

Job Description

1. Overall accountability for the execution, validation and commercialization of all projects within the company.

2. Overall accountability for the assembly process setup and process development of new product introduction (NPI) projects.

3. Manage and supervise the project teams’ day to day activities towards delivering projects on time, on budget, in compliance with the required standards/regulations and meeting customer’s expectations.

4. Coach and provide technical support to the project, process and validation teams as required.

5. Liaise with customers on all matters related to the successful commercialization of all projects.

6. Coordinate and work with other internal departments to facilitate smooth flow of activities for achieving project’s objectives and milestones.

7. Conduct regular project team meetings to review and track project progress.

8. Compile and communicate project summary with management.

9. Provide technical support to business development (BD) and costing teams as required on request for quotation (RFQ) activities.

10. Provide technical support to continuous improvement (CI) activities.

11. Perform any other duties as assigned.

Job Requirement

• - Diploma/Bachelor/Masters in Mechanical engineering / Manufacturing engineering/ Other engineering disciplines
• -Minimum 6 years of industrial technical experience including project/program management experience.
• -Minimum 4 years of experience in medical device manufacturing in a regulated environment (FDA 21 CFR Part 820 or equivalent).
• -Experience with Medical Device Directive (MDD), ISO 13485 and FDA design control.
• -Strong knowledge in extrusion, molding and assembly processes used in medical device manufacturing and exposure to sterilization processes.
• -Knowledge and experience in process validations.
• -Exposure to product development of medical devices.
• -Broad knowledge and experience in polymer materials processing.
• -Effective leadership with good communication, presentation, analytical and interpersonal and problem-solving skills.