Process Engineer

Knowles Electronics; Seberang Perai; On-site; MYR 50,000 - 80,000; Full time

Job summary

A leading electronics manufacturer located in Penang, Malaysia, is seeking a Process Engineer responsible for developing and optimizing stamping processes to meet quality standards. The candidate will drive continuous improvement initiatives, perform equipment validations, and ensure compliance with ISO 13485. A bachelor's degree in engineering and at least 2 years in a metal stamping or precision manufacturing environment are required. The role involves close collaboration across departments to support new product introductions and improve overall production efficiency.

Qualifications

• Minimum 2 years of experience in metal stamping or precision manufacturing environment.
• Hands-on experience in process troubleshooting and improvement.
• Familiarity with GD&T and engineering practices.

Responsibilities

• Design, develop, and improve manufacturing processes for metal stamped parts.
• Lead equipment and process validation activities.
• Troubleshoot production issues and drive root cause analysis.
• Ensure processes comply with ISO 13485 and maintain documentation.

Skills

Knowledge of stamping processes and tooling

ISO 13485 operation requirements

DOE, SPC, Six Sigma

Problem-solving methodologies

Experience with medical device manufacturing

Education

Bachelor’s degree in engineering

Tools

Statistical analysis

Validation protocols

Job description

Responsible for developing, optimizing, and sustaining stamping process and other value‑added processes (such as plating & annealing process, etc) to meet quality, safety, and regulatory standards (FDA, ISO 13485, GMP) while improving production efficiency, yield, and cost. Drives continuous improvement initiatives and supports new product introduction (NPI) activities. Knowledge of ISO 13485 requirements is an added advantage.

Main Role : Designs, improves and validates manufacturing processes.

Key Tasks : DOE, validation (IQ/OQ/PQ), PFMEA, troubleshooting complex issues, documentation for audits.

Regulatory Responsibility : Ensures compliance with ISO 13485, writes protocols/reports.

Technical Skills : Statistical analysis, validation protocols, root-cause analysis, process design.

Interaction : Works with R&D, quality, suppliers, and management.

Decision Level : Creates solutions and improvements; higher responsibility for process quality.

Output : Optimized, validated, documented processes.

Summary Description

Responsible for developing, optimizing, and sustaining stamping process and other value‑added processes (such as plating & annealing process, etc) to meet quality, safety, and regulatory standards (FDA, ISO 13485, GMP) while improving production efficiency, yield, and cost. Drives continuous improvement initiatives and supports new product introduction (NPI) activities. Knowledge of ISO 13485 requirements is an added advantage.

Main Role : Designs, improves and validates manufacturing processes.

Focus : Process development, optimization, validation, NPI.

Key Tasks : DOE, validation (IQ/OQ/PQ), PFMEA, troubleshooting complex issues, documentation for audits.

Regulatory Responsibility : Ensures compliance with ISO 13485, writes protocols/reports.

Technical Skills : Statistical analysis, validation protocols, root-cause analysis, process design.

Interaction : Works with R&D, quality, suppliers, and management.

Decision Level : Creates solutions and improvements; higher responsibility for process quality.

Output : Optimized, validated, documented processes.

Specific Duties And Responsibilities

1. Process Development & Optimization

• Design, develop, and improve manufacturing processes for metal stamp parts

• Identify and implement process improvements to reduce cycle time, scrap, and cost.

• Develop process flow, PFMEA, control plans, and work instructions.

2. Validation & Qualification

• Lead equipment and process validation activities:
  IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification).

• Prepare validation protocols and reports following regulatory guidelines.

• Conduct DOE (Design of Experiments) to optimize critical parameters.

3. Manufacturing Support

• Troubleshoot production issues (yield, deviations, non-conformities).

• Support daily operations with technical expertise to maintain stable processes.

• Drive root cause analysis using tools like 5 Why, Fishbone, DMAIC.

4. Regulatory & Quality Compliance

• Ensure processes comply with ISO 13485 and internal QMS.

• Maintain documentation according to regulatory and audit requirements.

• Participate in internal and external audits when needed.

5. Equipment & Automation

• Specify, qualify, and improve production equipment, jigs, and automation systems.

• Collaborate with suppliers and equipment vendors for upgrades and troubleshooting.

6. Cross-Functional Collaboration

• Work closely with R&D, Quality, Regulatory, Production, and Supply Chain.

• Support new product introduction (NPI) from prototype to mass production.

• Provide training to operators and technicians on new or improved processes.

7. Perform any other tasks as assigned by the superior.

Position Requirement

Education :Bachelor’s degree in engineering (Mechanical, Biomedical, Manufacturing or related discipline.

Experience :Minimum 2 years in metal stamping or precision manufacturing environment.

Skill

• Strong knowledge of stamping processes and tooling. Familiar with GD&T and engineering practices.
• Strong understanding of ISO 13485 operation requirements
• DOE, SPC, Six Sigma, problem-solving methodologies
• Experience with medical device manufacturing (metal stamping, packaging, passivation/sterilization, annealing).
• Familiarity with equipment validation and statistical analysis.

Special Requirement

Hands‑on experience in process troubleshooting and improvement. Knowledge of ISO 13485 is an added advantage.