Engineer II, Manufacturing Process Engineering

Medifox DAN GmbH; Kulai; On-site; MYR 80,000 - 120,000; Full time

Job summary

Medifox DAN GmbH is seeking a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will collaborate with Production, Quality, Product Development, Supply Chain, and Global Engineering to ensure safe, compliant, efficient, and scalable operations.

This role emphasizes technical problem solving, project execution, and cross-functional teamwork in a regulated medical device environment, including NPI activities and process improvement

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechatronics Engineering, Biomedical Engineering, Industrial Engineering, or related discipline.
• Minimum 2-4 years of Manufacturing Engineering experience within a regulated manufacturing environment.
• Experience with process validation (IQ/OQ/PQ).
• Experience supporting production and manufacturing operations.
• Strong root cause analysis and troubleshooting skills.

Responsibilities

• Provide technical leadership and engineering support to mask manufacturing operations.
• Investigate and resolve manufacturing process, equipment, and product quality issues.
• Lead root cause investigations utilizing structured problem-solving tools.
• Drive CAPA implementation and effectiveness verification.
• Support production performance targets for safety, quality, delivery, and cost.
• Develop and optimize manufacturing processes to improve capability, reliability, quality, and productivity.
• Establish process controls and monitoring strategies.
• Conduct process characterization and capability analysis.
• Identify opportunities for process automation, error-proofing, and waste reduction.
• Support capacity and line balancing initiatives to meet business demand.

Skills

Root cause analysis

Troubleshooting

CAPA implementation

Lean manufacturing

Six Sigma

Statistical tools

Process validation

IQ/OQ/PQ

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Manufacturing Engineering

Bachelor's Degree in Mechatronics Engineering

Tools

SolidWorks

AutoCAD

Minitab

Job description

Role Summary

The Manufacturing Engineer II is responsible for developing, optimizing, validating, and sustaining manufacturing processes for mask products throughout their lifecycle. This role serves as a key technical contributor within the Product Focus Team (PFT), supporting daily manufacturing operations while driving continuous improvement, process capability enhancement, automation initiatives, and New Product Introduction (NPI) activities.

The successful candidate will work closely with Production, Quality, Product Development, Supply Chain, and Global Engineering teams to ensure manufacturing processes are safe, compliant, efficient, and scalable. The role requires a strong balance of technical problem-solving, project execution, and cross-functional collaboration in a regulated medical device manufacturing environment. Based on the responsibilities defined in the organization's Manufacturing Engineering job descriptions, the role supports production, validation, process development, manufacturability, and continuous improvement activities.

Key Responsibilities

Product Focus Team (PFT) Support

• Provide technical leadership and engineering support to mask manufacturing operations.
• Investigate and resolve manufacturing process, equipment, and product quality issues.
• Lead root cause investigations utilizing structured problem-solving tools.
• Drive CAPA implementation and effectiveness verification.
• Support production performance targets for safety, quality, delivery, and cost.

Manufacturing Process Development & Optimization

• Develop and optimize manufacturing processes to improve capability, reliability, quality, and productivity.
• Establish process controls and monitoring strategies.
• Conduct process characterization and capability analysis.
• Identify opportunities for process automation, error-proofing, and waste reduction.
• Support capacity and line balancing initiatives to meet business demand.

Validation & Compliance

• Develop and execute validation activities including: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)
• Ensure manufacturing processes remain in a validated state.
• Support risk management activities including PFMEA and process risk assessments.
• Maintain compliance with: ISO 13485 FDA QSR GMP Internal Quality System requirements.

Continuous Improvement

• Lead Lean Manufacturing and Continuous Improvement projects.
• Identify and implement opportunities to: Improve yield Reduce scrap Reduce downtime Increase productivity Improve ergonomics
• Develop fixtures, tooling, and automation solutions to improve process robustness.
• Utilize engineering and statistical tools to support decision-making.

Cross-Functional Collaboration

• Collaborate with: Production Quality Engineering Product Development Supply Chain Supplier Quality Global Engineering teams
• Support audits, inspections, and compliance activities.
• Provide technical mentoring to graduate engineers, technicians, and interns.
• Participate in global engineering initiatives and technology transfer programs.

Qualifications

Required

• Bachelor's Degree in: Mechanical Engineering Manufacturing Engineering Mechatronics Engineering Biomedical Engineering Industrial Engineering Or related discipline
• Minimum 2-4 years of Manufacturing Engineering experience within a regulated manufacturing environment.
• Experience with process validation (IQ/OQ/PQ).
• Experience supporting production and manufacturing operations.
• Strong root cause analysis and troubleshooting skills.

Preferred

• Medical device manufacturing experience.
• Knowledge of ISO 13485, FDA QSR, and GMP requirements.
• Experience with statistical tools and process capability analysis.
• Lean Manufacturing and Six Sigma knowledge.
• Experience supporting global product transfers and manufacturing scale-up activities.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.