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.

Skills Required