Senior Manufacturing Engineer (Injection Molding / Extrusion / Braiding)

TALENTVUE PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

TALENTVUE PTE. LTD. in Singapore seeks a Manufacturing Engineer to optimize high‑volume biomedical device manufacturing processes. You will develop tooling, support NPI, and drive process validations to ensure quality and efficiency.

Applicants should have a Bachelor’s degree in engineering and 5–8 years of manufacturing engineering experience, ideally in medical devices such as catheters, with strong knowledge of DOE, FMEA, IQ/OQ/PQ, and GMP/ISO 13485 requirements.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5–8 years of manufacturing engineering experience in a high-volume production environment.
• Medical device manufacturing experience, preferably catheter production, is an advantage.
• Strong knowledge of process validation, DOE, statistical analysis, FMEA, IQ/OQ/PQ, and GMP/ISO 13485 requirements.

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.

Skills

Manufacturing engineering

DOE

Statistical analysis

FMEA

IQ/OQ/PQ

GMP/ISO 13485

Process validation

Education

Bachelor's Degree in Engineering

Job description

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.