Manufacturing Process Engineer - Medical Devices

Quasar Medical; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Quasar Medical in Singapore is seeking an engineering professional to support high-volume production with new product introduction, process engineering, and sustaining engineering. You will design and develop manufacturing processes, qualifications, and tooling, improve throughput, and ensure GMP/ISO13485 compliance while maintaining EHS standards.

This role requires 5–8 years in medical device manufacturing, CAD proficiency, and strong documentation skills, with willingness to work rotating

Qualifications

• 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.
• Proficiency with CAD software is required.
• Knowledgeable in DOE and statistical techniques (SPC).
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.

Responsibilities

• Evaluates/ improves manufacturing processes through designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials.
• 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.
• Lead and drive process qualifications and validations including equipment qualification 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.
• Maintain and comply with EHS, ISO13485, GMP, FDA regulations and GDP requirements.
• Required to perform rotating shift duties, including evening and night shifts, and may be assigned different roles within the team to support operational needs.

Skills

Interpersonal skills

Communication

DOE

SPC

Problem solving

Education

Bachelor's in Engineering

Tools

CAD software

Job description

Quasar Medical in Singapore is seeking an engineering professional to support high-volume production with new product introduction, process engineering, and sustaining engineering. You will design and develop manufacturing processes, qualifications, and tooling, improve throughput, and ensure GMP/ISO13485 compliance while maintaining EHS standards.

This role requires 5–8 years in medical device manufacturing, CAD proficiency, and strong documentation skills, with willingness to work rotating