Manufacturing Engineer

6 days ago

Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

**Essential Duties and Responsibilities**:
Include the following. Other duties may be assigned.
- 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.

**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.
- 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.

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