Key Responsibilities
- Develop, optimize, and troubleshoot manufacturing processes, tooling, and fixtures.
- Support new product introduction (NPI), process transfers, and process validations (IQ/OQ/PQ).
- Drive continuous improvement initiatives to improve yield, throughput, and operational efficiency.
- Conduct root cause analysis and implement corrective actions for manufacturing issues.
- Support equipment qualification, maintenance coordination, and process capability studies.
- Ensure compliance with GMP, ISO 13485, FDA regulations, and quality system requirements.
- Prepare and maintain manufacturing documentation, validation protocols, and technical reports.
Requirements
- Bachelor's Degree in Engineering or a related technical field.
- 5-8 years of manufacturing engineering experience in a high-volume production environment.
- Medical device manufacturing experience, preferably in catheter production, is an advantage.
- Strong knowledge of process validation, DOE, statistical analysis, FMEA, IQ/OQ/PQ, and GMP/ISO 13485 requirements.
Kindly email your resume in a comprehensive Word format to [Confidential Information]
We regret to inform that only shortlisted candidates will be notified.
Please be informed that by applying for the advertised position, the candidate is considered to have given their consent for us to collect, utilize, or disclose their personal information for the purposes related to the services we provide.
Jacqueline Goh
EA License Number: 22C1430
Registration Number: R1326664
