Manufacturing Engineer(Extrusion)

Quasar Medical | Medical Device Manufacturer; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Quasar Medical | Medical Device Manufacturer in Singapore seeks an experienced Process Engineer to lead manufacturing improvements for balloon catheter, extrusion, braid and shaft coil lines. You will develop, validate and transfer processes, design fixtures, and drive cost-effective solutions across high-volume production.

Candidates should have strong DOE/ SPC skills, CAD proficiency, and a track record in GMP/ISO13485 environments, with 5–8 years in medical device manufacturing.

Qualifications

• Bachelor in Engineering or similar technical field with 5–8 years’ experience in a high-volume production environment in the medical device sector.
• Experience with catheter production techniques is preferred.
• Proficient in DOE and SPC; knowledge of GMPs, ISO13485 and FDA.
• Strong documentation and record management; able to manage Engineering Change Orders.

Responsibilities

• Evaluates and improves manufacturing processes through design of research programs and collaboration with vendors and operators.
• Designs and develops manufacturing processes for new products and changes, including tooling and fixtures.
• Troubleshoots processes and refines to improve throughput; designs fixtures and assembly methods.
• Analyzes workflow, space needs and equipment layouts to boost efficiency.
• Conducts process qualifications and validations including equipment qualification and material specs.
• Documents and reports findings; computes production costs and estimates future requirements.
• Ensures health and safety within assigned areas and maintains compliance with EHS, GMP and ISO13485.

Skills

Interpersonal skills

DOE

SPC

Process capability

Control charts

Documentation

Engineering Change Order

Education

Bachelor in Engineering or equivalent technical field

Tools

CAD software

Job description

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:

Include the following:

• Evaluates/ improves manufacturing processes through designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• 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.

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.