Junior Manufacturing Engineer
6 days ago
Job Description
The scope of this role is to support line validation, optimize manufacturing processes, and work closely with cross-functional teams to ensure product quality, efficiency, and compliance with Quasar, ISO, and industry standards. Areas of coverage include the Legacy Catheter line, Extrusion, Braiding, and Shaft Coil line in Singapore. The role involves developing and improving manufacturing processes by studying product and manufacturing methods across all areas of Quasar Singapore.
Position Location
QSG Singapore
**Responsibilities**:
Assist and evaluate manufacturing processes by conducting necessary line audits or validation through knowledge of product design, fabrication, assembly, tooling, and materials, with communication with vendors and input from operators.
Validate manufacturing processes for new products, product changes, and enhancements, as well as related tooling and fixtures.
Troubleshoot processes and implement refinements to improve product throughput, fixture design, and assembly techniques.
Improve manufacturing efficiency by analyzing and planning workflows, space requirements, and equipment layout.
Conduct process qualifications and validations, including equipment qualifications and material specifications.
Ensure product and process quality by designing testing methods, testing finished product and process capabilities, and establishing standards.
Provide manufacturing decision-making information by calculating production, labor, and material costs, reviewing production schedules, and estimating future requirements.
Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
Responsible for health and safety within assigned areas, including accident investigation and corrective action.
Conduct proof of concept for new technologies or methodologies that could provide competitive advantages and cost benefits to Quasar or customers.
Maintain and comply with ISO13485, GMP, and FDA regulations.
**Requirements**:
Bachelor’s degree in Engineering or a similar technical field with 2 to 5 years of experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred.
Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
Proficient in DOE and statistical techniques. Certified LEAN/6Sigma preferred.
Knowledgeable in defining process capabilities and control charting.
Experience writing protocols for validations and qualifications, including FMEA, MVP, IQ/OQ, and TMV protocol preparation.
Knowledge of FDA, GMPs, ISO 9001, ISO13485, and Medical Device Directives.
Self-motivated and a driver of change and innovation, capable of working in a fast-paced environment with mínimal supervision.
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