job description
Are you a seasoned Manufacturing Engineer with expertise in plastics injection molding and tooling processes? RecruitPedia Pte Ltd is seeking a dynamic Senior Manufacturing Engineer to lead high-precision manufacturing operations in the medical devices sector in Bali, Indonesia.
In this pivotal role, you will drive innovation in injection molding techniques, optimize tooling and process efficiency, and ensure compliance with industry standards (ISO 13485, FDA, GMP). Your expertise will be instrumental in enhancing product quality, reducing waste, and scaling production for a global market.
Join a forward-thinking team in one of Southeast Asia’s most vibrant regions—Bali—where cutting-edge engineering meets a thriving industrial ecosystem. This is a unique opportunity to advance your career while contributing to life-saving medical technologies.
Responsibility
- Lead the design, development, and optimization of plastics injection molding processes for medical device components.
- Oversee tooling design, fabrication, and validation to ensure precision and repeatability in high-volume production.
- Implement lean manufacturing principles and Six Sigma methodologies to improve efficiency and reduce defects.
- Collaborate with cross-functional teams (R&D, QA, Production) to troubleshoot process deviations and drive continuous improvement.
- Ensure compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 820) and internal quality systems.
- Develop and maintain process documentation, including SOPs, work instructions, and PFMEAs.
- Evaluate and integrate new materials, technologies, and automation to enhance manufacturing capabilities.
- Mentor junior engineers and technicians, fostering a culture of technical excellence and innovation.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field; Master’s preferred.
- Minimum 7+ years of experience in plastics injection molding and tooling process engineering, with at least 3 years in the medical devices industry.
- Proven expertise in mold design, process validation (IQ/OQ/PQ), and DOE (Design of Experiments).
- Strong knowledge of regulatory requirements for medical devices (ISO 13485, FDA, MDSAP).
- Proficiency in CAD/CAM software (e.g., SolidWorks, AutoCAD) and molding simulation tools (e.g., Moldflow).
- Experience with statistical process control (SPC) and root cause analysis (RCA) tools.
- Excellent project management and problem-solving skills with a data-driven approach.
- Fluency in English; knowledge of Bahasa Indonesia is a plus.