job description
Are you a visionary Principal Engineer with expertise in LSR (Liquid Silicone Rubber) molding and medical device manufacturing? RecruitPedia Pte Ltd is seeking a dynamic leader to spearhead process validation, technology development, and operational excellence in our cutting-edge production facility in Bali, Indonesia.
In this high-impact role, you will drive innovation in LSR molding processes, ensuring compliance with ISO 13485, FDA, and GMP standards while optimizing efficiency, quality, and scalability. Your leadership will shape the future of medical device manufacturing, leveraging advanced engineering principles to solve complex challenges in a fast-paced, global environment.
Join a forward-thinking team where your expertise will directly influence product development, regulatory approvals, and operational best practices. This is a rare opportunity to lead transformative projects in one of the most exciting sectors of engineering today.
Responsibility
- Lead the design, development, and validation of LSR molding processes for high-precision medical devices.
- Oversee process optimization to improve yield, reduce waste, and enhance product consistency.
- Ensure compliance with ISO 13485, FDA QSR, and EU MDR regulatory requirements for medical device manufacturing.
- Collaborate with cross-functional teams (R&D, Quality, Production) to scale manufacturing processes from prototype to mass production.
- Develop and implement advanced process monitoring and control systems (e.g., SPC, DOE, Six Sigma).
- Mentor engineering teams and provide technical leadership in material science, tooling design, and automation.
- Drive continuous improvement initiatives using Lean Manufacturing and Kaizen methodologies.
- Support new product introductions (NPI) with DFM (Design for Manufacturability) and risk assessment (FMEA).
Qualifications
- Bachelor’s or Master’s degree in Mechanical, Chemical, or Manufacturing Engineering (or related field).
- Minimum 10+ years of experience in LSR molding, medical device manufacturing, or precision engineering.
- Proven track record in process validation (IQ/OQ/PQ) and regulatory submissions (510(k), CE Marking).
- Expertise in statistical process control (SPC), DOE, and root cause analysis.
- Strong knowledge of cleanroom manufacturing, sterilization processes, and biomaterial compatibility.
- Experience with CAD/CAM software (SolidWorks, AutoCAD) and molding simulation tools (Moldflow, SIGMASoft).
- Excellent project management skills with the ability to lead cross-functional teams.
- Fluency in English; additional languages (e.g., Indonesian) are a plus.