job description
Join Mehow Medical (M) Sdn Bhd, a leading innovator in medical device manufacturing, as a Senior Tooling Engineer in the vibrant city of Denpasar, Bali. This is a unique opportunity to drive excellence in tooling development, new product introduction (NPI), and precision mold testing for cutting-edge medical products.
In this role, you will oversee the entire tooling lifecycle—from design and fabrication to validation and maintenance—ensuring seamless production processes and adherence to stringent medical industry standards. Your expertise will directly impact product quality, efficiency, and innovation in a fast-paced, technology-driven environment.
We offer a competitive salary, professional growth opportunities, and the chance to work in one of Southeast Asia’s most dynamic and culturally rich locations. If you are passionate about engineering precision and advancing healthcare solutions, we want to hear from you.
Responsibility
- Develop and manage tooling schedules to ensure on-time delivery of high-precision molds and components for medical devices.
- Lead New Product Introduction (NPI) processes, collaborating with cross-functional teams to transition designs from prototype to mass production.
- Conduct test mold trials, analyzing results to optimize tool performance, durability, and product quality.
- Design, modify, and validate tooling solutions using CAD/CAM software (e.g., SolidWorks, AutoCAD) to meet medical industry specifications.
- Troubleshoot tooling-related issues during production, implementing corrective actions to minimize downtime.
- Ensure compliance with ISO 13485, FDA, and GMP standards for medical device manufacturing.
- Coordinate with suppliers and vendors for tooling procurement, fabrication, and maintenance.
- Document all tooling processes, changes, and validations for traceability and regulatory audits.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field; Master’s degree is a plus.
- Minimum 5 years of experience in tooling engineering, preferably in the medical device or precision manufacturing industry.
- Proficient in CAD/CAM software (e.g., SolidWorks, NX, or Pro/E) and tooling design principles.
- Strong knowledge of injection molding, die casting, and precision machining processes.
- Experience with NPI processes, DFM (Design for Manufacturing), and lean manufacturing methodologies.
- Familiarity with medical device regulations (ISO 13485, FDA 21 CFR Part 820) is highly desirable.
- Excellent problem-solving skills and the ability to work under tight deadlines in a fast-paced environment.
- Strong communication and project management skills to liaise with global teams.