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Manufacturing Process Optimization Specialist
2 months ago
We are seeking a highly motivated and detail-oriented individual to join our team as a Manufacturing Process Optimization Specialist. This is an exciting opportunity to work with a dynamic organization that values innovation, collaboration, and continuous improvement.
About the RoleAs a Manufacturing Process Optimization Specialist at Quasar Medical (Singapore) Pte. Ltd., you will be responsible for evaluating manufacturing processes, supporting research programs, and collaborating with operators and vendors to improve product throughput and assembly techniques. You will also design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
Key Responsibilities- Evaluate manufacturing processes to identify areas for improvement and implement changes to increase efficiency and productivity.
- Support research programs by applying knowledge of product design and materials to develop innovative solutions.
- Collaborate with operators and vendors to troubleshoot process issues and implement corrective actions.
- Design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
- Analyze workflow, space requirements, and equipment layout to improve manufacturing efficiency.
- Participate in process qualifications and validations, including equipment qualifications and material specifications.
- Ensure product and process quality by supporting the design of testing methods and confirming manufacturing processes.
- Provide manufacturing decision-making information by assisting in calculations of production, labor, and material costs, and reviewing production schedules.
- Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
- Maintain compliance with ISO 13485, GMP, and FDA regulations.
- Bachelor's degree in Engineering or a similar technical field.
- Up to 2 years of experience in a high-volume production environment; experience in medical device manufacturing, particularly catheter production, is a plus.
- Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
- Basic understanding of DOE and statistical techniques.
- Familiarity with process capabilities and control charting is preferred.
- Exposure to writing protocols for validations and qualifications, including FMEA and IQ/OQ documentation.
- Awareness of GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
- Self-motivated and eager to drive change and innovation.
We offer a competitive salary of SGD $80,000 - $100,000 per annum, depending on experience, as well as opportunities for professional growth and development in a fast-paced and dynamic environment.
