Engineering Manager

Ambition; Selangor; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading firm in manufacturing engineering is looking for a skilled engineer to ensure compliance with ISO 13485 and manage engineering projects. The ideal candidate will have a Bachelor's Degree in Engineering, at least 5 years of relevant experience, and a strong understanding of regulatory standards. This role involves leading new product introductions and optimizing production processes in a dynamic environment.

Qualifications

• Minimum 5 years of experience in engineering management or project management.
• Experience in an ISO 13485-certified manufacturing environment is a plus.
• Strong knowledge of FDA 21 CFR Part 820 and GMP requirements.

Responsibilities

• Ensure full compliance with ISO 13485 and related standards.
• Lead new product introduction and improvement projects.
• Monitor machine downtime and optimize production equipment performance.

Skills

Compliance with ISO 13485

Project management

Process optimization

Technical support

Lean Manufacturing

Education

Bachelor’s Degree in Engineering, Science, or related field

Job description

Key Responsibilities

• Ensure full compliance with ISO 13485, GMP, and relevant product and regulatory standards.
• Lead new product introduction (NPI) and improvement projects, including technical support for manufacturing and customers.
• Oversee material evaluation, process development, validation, and revalidation activities.
• Monitor machine downtime and ensure optimal performance of production equipment.
• Drive process efficiency, preventive maintenance programs, and Lean Manufacturing initiatives.
• Manage and deliver process engineering and improvement projects on time and within budget.
• Lead cost reduction and process optimization programs across operations.
• Evaluate competitor products and stay updated with the latest technological advancements.
• Review and assess change requests from suppliers and customers to ensure quality and compliance.

Key Requirements

• Bachelor’s Degree in Engineering, Science, or a related technical discipline.
• Minimum 5 years of experience in engineering management, project management, or R&D—preferably in moulding, assembly, or automation processes.
• Experience in an ISO 13485-certified manufacturing environment is an advantage.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Innovative, proactive, and able to work independently with minimal supervision.