JOB SUMMARY:
The scope of this role is to support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore and develop, improves manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following. Other duties may be assigned.
· Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
· Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
· Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
· Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
· Process qualifications and validations including equipment qualifications and material specifications.
· Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
· Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
· Prepares product and process reports by collecting, analysing, and summarizing information and trends.
· Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
· Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
· Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
· Oversee and drive Validation Activities.
· Maintain and comply with ISO13485, GMP and FDA regulations.
SUPERVISORY RESPONSIBILITIES:
N.A.
Education/Experience and Qualifications:
- Availability to travel to sending site for duration of onsite training
- Bachelor in Engineering or similar technical field with 5 to 8 years’ 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.
- Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
- Working knowledge of standard machine shop equipment is required.
· Proficiency with CAD software is required.
· Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
- Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.
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.
Controlled Environment (Class 100K cleanroom) and office area.
