job description
Are you a seasoned Senior Manufacturing Engineer or Engineering Manager with expertise in Plastic Injection Molding for the Medical Devices industry? RecruitPedia Pte Ltd is seeking a dynamic leader to drive innovation, optimize production processes, and ensure the highest quality standards in our cutting-edge manufacturing facility in Bali.
In this pivotal role, you will oversee the end-to-end injection molding operations, from tooling and process development to quality control and team leadership. Your expertise will be instrumental in enhancing efficiency, reducing waste, and maintaining compliance with stringent medical device regulations (e.g., ISO 13485, FDA). This is a unique opportunity to transition from a hands-on engineering role into a strategic leadership position, shaping the future of our manufacturing excellence.
Join a forward-thinking company committed to advancing healthcare through precision engineering. If you thrive in a fast-paced, collaborative environment and are passionate about delivering flawless products, we want to hear from you.
Responsibility
- Lead and mentor a team of engineers and technicians in plastic injection molding operations, fostering a culture of continuous improvement.
- Develop, optimize, and validate molding processes, tooling designs, and material selections to meet medical device specifications.
- Ensure compliance with ISO 13485, FDA QSR, and other regulatory standards for medical device manufacturing.
- Collaborate with R&D, quality assurance, and production teams to resolve technical challenges and improve product consistency.
- Implement lean manufacturing and Six Sigma methodologies to reduce defects, cycle times, and material waste.
- Oversee equipment maintenance, troubleshooting, and calibration to minimize downtime and maximize OEE (Overall Equipment Effectiveness).
- Manage vendor relationships for raw materials, tooling, and secondary operations, ensuring cost-effective and high-quality supply chains.
- Drive process automation and Industry 4.0 initiatives (e.g., IoT, data analytics) to enhance production efficiency.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Polymer Science, or a related field. Master’s degree is a plus.
- Minimum 8+ years of experience in plastic injection molding, with at least 3 years in a leadership or managerial role.
- Proven expertise in medical device manufacturing with deep knowledge of cleanroom environments, validation (IQ/OQ/PQ), and regulatory compliance.
- Strong proficiency in molding software (e.g., Moldflow, SolidWorks) and statistical process control (SPC) tools.
- Experience with tool design, DFM (Design for Manufacturability), and material science (e.g., thermoplastics, elastomers).
- Excellent problem-solving skills with a data-driven approach to root cause analysis (e.g., 8D, Fishbone Diagram).
- Certifications in Six Sigma (Green Belt/Black Belt), Lean Manufacturing, or Project Management (PMP) are highly desirable.
- Strong communication and stakeholder management skills to liaise with cross-functional teams and senior leadership.