Engineer II, Manufacturing Process Engineering

ResMed Inc; Johor Bahru; On-site; MYR 60,000 - 120,000; Full time

Job summary

ResMed Inc. in Malaysia seeks a Manufacturing Engineer II to develop, optimize, validate, and sustain manufacturing processes for mask products. You will work across Production, Quality, Product Development, and Global Engineering to improve safety, efficiency, and scalability in a regulated medical device environment.

The role emphasizes hands-on problem solving, CAPA ownership, process validation (IQ/OQ/PQ), and cross-functional collaboration to meet quality, delivery, and cost targets.

Qualifications

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

Responsibilities

• Support mask manufacturing operations and resolve process issues.
• Lead CAPA implementation and effectiveness verification.
• Develop and optimize manufacturing processes for capability, reliability, quality and productivity.
• Validate processes per IQ/OQ/PQ and maintain validated state.
• Collaborate with cross-functional teams and support audits and compliance.

Skills

Root cause analysis

Troubleshooting

Problem solving

Cross-functional collaboration

Lean Manufacturing

Six Sigma

Statistical tools

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Manufacturing Engineering

Bachelor's Degree in Mechatronics Engineering

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Industrial Engineering

Tools

Statistical software (e.g., Minitab)

Job description

Role SummaryThe 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 ResponsibilitiesProduct Focus Team (PFT) SupportProvide 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 & OptimizationDevelop 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 & ComplianceDevelop 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 ImprovementLead Lean Manufacturing and Continuous Improvement projects.Identify and implement opportunities to: Improve yield Reduce scrap Reduce downtime Increase productivity Improve ergonomicsDevelop fixtures, tooling, and automation solutions to improve process robustness.Utilize engineering and statistical tools to support decision-making.Cross-Functional CollaborationCollaborate with: Production Quality Engineering Product Development Supply Chain Supplier Quality Global Engineering teamsSupport audits, inspections, and compliance activities.Provide technical mentoring to graduate engineers, technicians, and interns.Participate in global engineering initiatives and technology transfer programs.QualificationsRequiredBachelor's Degree in: Mechanical Engineering Manufacturing Engineering Mechatronics Engineering Biomedical Engineering Industrial Engineering Or related disciplineMinimum 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.PreferredMedical 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.