Manufacturing Process Engineer

3 weeks ago


Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time
Job Summary

As a Manufacturing Process Engineer with Quasar Medical (Singapore) PTE. LTD., you will play a crucial role in developing and improving manufacturing processes for new products and enhancements. This includes designing and implementing process improvements, collaborating with operators and vendors, and ensuring product and process quality.

Key Responsibilities
  • Design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
  • Support process troubleshooting and refinements to improve product throughput and assembly techniques.
  • Contribute to improving manufacturing efficiency by analyzing workflow, space requirements, and equipment layout.
  • Participate in process qualifications and validations, including equipment qualifications and material specifications.
  • Assist in ensuring product and process quality by supporting the design of testing methods and confirming manufacturing processes.
  • Provide manufacturing decision-making information by assisting in calculations of production, labor, and material costs, and reviewing production schedules.
  • Help prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Assist in keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and procedures.
  • Support Health & Safety initiatives in assigned areas, including accident investigation and corrective actions.
  • Research state-of-the-art process technologies and evaluate their potential benefits.
  • Participate in Validation Activities as directed.
  • Assist in maintaining compliance with ISO 13485, GMP, and FDA regulations.

Requirements

  • Bachelor's degree in Engineering or a similar technical field.
  • Up to 2 years of experience in a high-volume production environment; experience in medical device manufacturing, particularly catheter production, is a plus.
  • Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
  • Basic understanding of DOE and statistical techniques.
  • Familiarity with process capabilities and control charting is preferred.
  • Exposure to writing protocols for validations and qualifications, including FMEA and IQ/OQ documentation.
  • Awareness of GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
  • Self-motivated and eager to drive change and innovation. Must be comfortable working in a fast-paced environment with minimal supervision.

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