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npi project engineer

2 weeks ago

Batu Kawan, Penang, Malaysia Pentamaster Corporation Berhad Full time 80,000 - 120,000 per year
JOB OBJECTIVE

The NPI Engineer (Product Transfer) will be responsible for managing the end-to-end transfer of medical device products from external business partners to our manufacturing facility. This role involves overseeing the transition of manufacturing processes, ensuring compliance with industry standards, and coordinating cross-functional teams to facilitate smooth and efficient product transfers.

MAIN RESPONSIBILITIES AND DUTIES

3.1. Coordinate Product Transfers:

3.1.1. Serve as the primary point of contact between external partners and internal teams for product transfers.

3.1.2. Manage the overall transfer process of medical device products, ensuring timely and accurate movement from external partners to the factory.

3.2 Process Review & Documentation:

3.2.1. Review and document the manufacturing processes provided by external partners.

3.2.2. Ensure all processes are clearly understood, standardized, and optimized for in-house production.

3.2.3. Ensure compliance with regulatory requirements, such as FDA, ISO, and other relevant industry standards.

Cross-functional Collaboration:

3.3.1. Work closely with Quality Control, Production, and Regulatory teams to ensure a smooth transition of product manufacturing.

3.3.2. Collaborate with internal stakeholders to identify any potential process gaps and ensure alignment between external partner and internal capabilities.

3.4 Risk Assessment and Mitigation:

3.4.1. Conduct risk assessments of product transfers and manufacturing processes to identify potential issues early on.

3.4.2. Implement corrective and preventive actions as necessary to mitigate risks and ensure continuous improvement.

3.5 Training and Knowledge Transfer:

3.5.1. Develop and deliver training materials for internal teams to understand the

3.5.2. new processes and requirements from external partners. Provide ongoing support and guidance to internal teams during the transfer phase.

3.6 Process Optimization:

3.6.1. Identify opportunities to improve the efficiency and effectiveness of the transferred manufacturing processes.

3.6.2. Collaborate with production teams to implement process improvements and reduce waste.

3.7 Compliance and Regulatory Assurance:

3.7.1. Ensure all transferred processes comply with relevant medical device regulations and industry best practices.

3.7.2. Work with the regulatory affairs team to prepare necessary documentation for product registration and approvals.

3.8. Troubleshooting and Problem Solving:

3.8.1. Act as a point of escalation for issues related to product transfer and manufacturing processes.

3.8.2. Lead troubleshooting efforts and provide solutions to resolve any process or product quality issues that may arise during transfer.