Engineering Manager

2 days ago

Klang, Selangor, Malaysia Mercuri Urval Full time

Job Title: Engineering Senior Manager/manager

Job Summary:

We are representing an international client in medical devices manufacturing and engineering sector to appoint a dynamic and results-driven engineering leader to oversee New Product Introduction (NPI), Process Engineering, and Facility Maintenance departments. The selected candidate will be responsible for all engineering activities including driving manufacturing excellence, ensuring regulatory compliance, and leading continuous improvement initiatives to enhance product quality, operational efficiency, and cost-effectiveness.

Key Responsibilities:

Strategic Leadership & Management:

  • Provide strategic direction and day-to-day leadership for the NPI, Process Engineering, and Facility Maintenance teams.
  • Develop and manage departmental budgets, resources, and performance metrics (KPIs)

New Product Introduction (NPI) & Process Development:

  • Lead cross-functional NPI projects from design transfer to stable production, ensuring on-time delivery and meeting cost targets.
  • Drive manufacturing process development, optimization, and scale-up for new and existing products.
  • Evaluate new materials, technologies, and competitor products

Operational Excellence & Continuous Improvement:

  • Champion Lean Manufacturing, Six Sigma, and cost-reduction programs to enhance process efficiency and profitability.
  • Analyze machine downtime and equipment performance; implement robust preventive maintenance programs to maximize OEE (Overall Equipment Effectiveness).
  • Initiate and manage capital and process improvement projects

Regulatory Compliance & Quality Assurance:

  • Serve as the primary engineering authority to ensure full compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and other relevant regulatory standards.
  • Oversee all validation and re-validation activities (IQ/OQ/PQ), process verification, and change control processes.
  • Review and approve technical change requests from suppliers and customers.

Technical Support & Collaboration:

  • Provide expert technical support to resolve production issues and support customer needs.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field (Master's degree preferred).
  • Minimum of 8 years of progressive experience in engineering, with at least 5 years in a project management or R&D (specific experience in moulding, automation and assembly is highly preferred).
  • Required: Proven working experience in an ISO 13485 certified environment.
  • Knowledge of FDA 21 CFR Part 820 and GMP is essential.
  • Leadership and team management skills
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Self-motivated, resourceful, and able to work independently with high initiative and creativity.
  • Effective communication and interpersonal skills, with the ability to collaborate across all levels of the organization.
  • Fluent in English and local languages

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