Job Description

Company Background

A global medical technology company dedicated to innovative non-invasive monitoring solutions and advanced healthcare technologies. The company is committed to improving patient outcomes and reducing healthcare costs through the development of cutting-edge devices and systems for hospitals, clinics, and homecare. With operations in Malaysia, it supports engineering, manufacturing, and R&D activities in full compliance with international standards.

Ensure molding production equipment and machinery run with minimal downtime and achieve low NCR rates. Provide technical support to Production, Engineering, and QC teams in process improvements, equipment repairs, troubleshooting automation/control systems, calibration, and process validation. Execute change requests and assess their impact on validated processes. Drive cost reduction and cost-saving initiatives, optimize carrier set-up and spare part management, and enhance carrier maintenance efficiency. Investigate process and quality issues arising from equipment or process-related problems, and implement permanent corrective actions. Train and coach technicians on carrier servicing and repair tasks. Foster a positive work ethic and mindset among engineering staff to maximize performance and contribution to the company. Evaluate and introduce new technologies to improve machine efficiency and product quality. Develop engineering study protocols, conduct data collection and analysis, and provide recommendations for further improvements when needed. Prepare URS and FDS technical documents for molding production equipment. Ensure all maintenance SOPs and documentation comply with OSHA, ISO 13485, GxP, and US regulatory standards. Maintain validated status by reviewing, updating, and approving release documents before implementation. Properly manage and control all maintenance records. Promote clear communication across all shifts, ensuring effective handovers and productive start-up meetings. Adhere to Masimo Values & Behaviors, the Alcon Code of Business Conduct, and comply with Masimo Health, Safety, and Environmental Standards.

Job Requirements

Minimum

5 years of experience

in automation, control systems, process engineering, equipment installation/maintenance, or calibration in high-volume manufacturing (preferably electronics, plastic molding, medical device, or pharmaceutical). Diploma or Bachelor's Degree in Engineering (Mechanical, Electrical, Mechatronics, or related fields).

Strong knowledge of injection molding machines, mold setup, scientific molding methodology, and peripheral equipment (e.g., dryers, controllers, robots).

Familiarity with QMS, GMP, ISO 13485, and US FDA Part 820 compliance. Skilled in troubleshooting, validation, statistical analysis, and proficient in using measurement tools (calipers, micrometers, GD&T). Proficient in PLC/PC-based machines and MS Office. Strong problem-solving, communication, and interpersonal skills. Minimum qualification: High School/Technical Certificate; Diploma or Bachelor's in Engineering preferred.

Willing to work in both office and production floor environments; occasional travel required; valid driving license needed.

Job Type: Full-time

Pay: RM5,500.00 - RM7,000.00 per month

Education:

Diploma/Advanced Diploma (Preferred)
Experience:

molding: 5 years (Preferred)
Work Location: In person