Maintain, troubleshoot, and optimize manufacturing equipment to ensure high uptime and production efficiency
Lead equipment setup, installation, qualification, and commissioning activities
Support New Product Introduction (NPI) and technology transfer projects
Validation & Compliance
Execute Installation Qualification (IQ) and support OQ/PQ validation activities
Ensure equipment and processes comply with regulatory standards (e.g. GMP, ISO 13485)
Support audit readiness and adherence to internal quality systems
Continuous Improvement
Drive continuous improvement initiatives focused on cost reduction, yield improvement, and cycle time optimization
Apply Lean Manufacturing and Six Sigma methodologies to enhance process performance
Lead Kaizen activities and foster a culture of operational excellence
Root Cause Analysis (RCA) & CAPA
Perform root cause analysis on equipment failures, downtime, and quality issues
Implement effective corrective and preventive actions (CAPA) to prevent recurrence
Documentation & Standardization
Develop and maintain Work Instructions (WI) and Standard Operating Procedures (SOPs)
Ensure accurate and complete documentation to support compliance and audit requirements
Technical Support
Provide timely technical support to production teams to resolve equipment-related issues
Collaborate cross-functionally with Quality, Production, and Maintenance teams
Qualifications & Experience
Education
Bachelor's Degree in Engineering (Mechanical, Electrical, Mechatronics, or related field)
Requirements
Minimum 3-5 years of experience in equipment engineering, preferably in the medical device or regulated manufacturing industry
Hands-on experience in equipment troubleshooting, maintenance, and optimization
Technical Competencies
Experience with:
Lean Manufacturing & Six Sigma methodologies (certification is a plus)
Equipment validation (IQ/OQ/PQ)
Root Cause Analysis (RCA) and CAPA
Development of WI and SOP documentation
Strong understanding of regulatory standards such as GMP, ISO 13485 , or similar
Soft Skills
Strong analytical and problem-solving skills
Proactive, self-driven, and able to work independently
Effective communication and collaboration skills
High level of ownership and accountability
Preferred Experience
Experience in medical device manufacturing or other highly regulated industries
Exposure to automation, precision equipment, or cleanroom environments
Strong alignment with a quality-driven and continuous improvement culture
#LI-APAC
Joining us is more than saying "yes" to making the world a healthier place. It's discov
Benefits
Health insuranceFlexible scheduleEquity / stock optionsPerformance bonus
Additional Information
Why Join ResMed?
Global Impact & Meaningful Mission : Your work will directly contribute to improving the lives of millions of people living with conditions like sleep apnea, COPD, and other chronic health issues. At ResMed, we're not just creating devices-we're transforming lives.
Innovation-Driven Culture : As a leader in digital health and connected medical devices, innovation is at the heart of what we do. It's not just a buzzword here-it's the foundation of how we approach every challenge.
Career Growth & Development : Whether you're just starting out or an experienced professional, ResMed offers clear career development paths, cross-functional opportunities, and a platform to make a significant impact.
Purpose-Led Values : We are guided by a deep commitment to sustainability, diversity, and improving the communities we serve. At ResMed, you'll have the chance to make a difference both inside and outside the workplace.
Collaborative & Inclusive Environment : Join a team of smart, passionate professionals who are eager to collaborate. We embrace a diverse, inclusive, and supportive culture where every voice is heard.
Cutting-Edge Technology : Work with the latest technologies-from cloud-connected devices to AI-driven insights-that are changing healthcare and improving outcomes for real people.
Wellness & Flexibility : We value work-life balance and offer flexible hybrid work options (for most roles), wellness programs, and a healthy work culture that promotes personal well-being.
Competitive Benefits : ResMed offers competitive compensation, bonus programs, health and wellness benefits, employee stock purchase plans, and more.
Award-Winning Employer : ResMed has been recognized globally as a top employer, innovator, and leader in the medical device industry.
Role Overview
We are seeking an experienced Equipment Engineer to support the development, maintenance, validation, and continuous improvement of manufacturing equipment. This role is critical in ensuring optimal equipment performance, product quality, and compliance with regulatory standards within a highly regulated environment.
You will play a key role in driving operational excellence, supporting production activities, and delivering engineering solutions aligned with Lean Manufacturing and Six Sigma principles .
Resmed · Johor Bahru, Malaysia