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 *************
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
Talentvue was started with a single-minded vision in mind: To provide the best-in-class talent acquisition for organisations that go beyond the recruitment process. With over a decade of human capital experience, Talentvue is well-positioned to offer talent sourcing, pre-employment due diligence services and human capital support services to aid you in your transformation journey.