Engineer Manufacturing

1 day ago

Singapore Manufacturing & Operations Full time

Job Description
The scope of this role is to support the Balloon Catheter line or Extrusion Braid and Shaft Coil line in Singapore. Develop and improve manufacturing processes by studying product and manufacturing methods across all areas of Quasar Singapore.
**Work Environment**:
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. The work involves a controlled environment (Class 10K/100K cleanroom) and office area.
Position Location
QSG Singapore

**Responsibilities**:
Design and develop manufacturing processes for new products, product changes, and enhancements, as well as related tooling and fixtures.
Troubleshoot processes, refine them to improve product throughput, and design fixtures and assembly techniques.
Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
Conduct process qualifications and validations, including equipment qualifications and material specifications.
Assure product and process quality by designing testing methods; test finished products and process capabilities; establish standards; confirm manufacturing processes.
Provide manufacturing decision-making information by calculating production labor and material costs; review production schedules; estimate future requirements.
Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
Keep equipment operational by coordinating maintenance and repair services; follow manufacturer’s instructions and established procedures; request special services as needed.
Responsible for Health & Safety within assigned areas, including accident investigation and corrective actions.
Investigate state-of-the-art process technologies and evaluate potential competitive advantages and the cost-benefit of their introduction.
Oversee and drive validation activities.
Maintain and comply with ISO 13485, GMP, and FDA regulations.
**Requirements**:
Availability to travel to the sending site for the duration of onsite training.
Bachelor’s degree in Engineering or a similar technical field with 5 to 8 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.
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 GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
Self-motivated and a driver of change and innovation. Must be willing to work in a fast-paced environment with mínimal supervision.

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