Engineer II, Manufacturing Engineering

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

Our Culture We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

Job Summary

• The scope of this role is to support Singapore operations covering scope assigned based on product and site need from new product introduction, new process engineering and sustaining engineering.
• The scope of this role is to support the production process, not limit but includes Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore. Develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.
• The candidate will cover duties and job assignment from product and/or process develop/ transfer/improve manufacturing processes by evaluating/ assessing product drawings/prints and manufacturing methods in all areas of Quasar Singapore.

Essential Duties and 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.
• Any other project or duties as assigned.
• Availability to travel if required.

Authority

• NA

Education/Experience and 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
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques (SPC).
• Knowledgeable in defining process capabilities and control charting.
• Strong and meticulous in documentation and record management. Ability to manage Engineering Change Order.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Proficiency with CAD software is required.
• 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.

Work Environment

• While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
• Controlled Environment (Class 10K/100K cleanroom) and office area.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority - it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously.

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives.