Senior Manufacturing Engineer

2 days ago


North Region, Singapore Quasar Medical (Singapore) Pte Ltd Full time $80,000 - $120,000 per year

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

  • Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
  • Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
  • Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
  • Improve efficiency by analyzing workflow, space, and equipment layout.
  • Process qualifications and validations including equipment qualifications and material specifications.
  • Lead process qualifications and validations, including equipment and material specifications.
  • Ensure product and process quality through testing and establishing standards.
  • Provide decision-making information by calculating costs and reviewing schedules.
  • Prepare reports by analyzing and summarizing trends.
  • Maintain equipment by coordinating maintenance and repairs.
  • Ensure Health & Safety, including accident investigation and corrective action.
  • Investigate and evaluate new process technologies.
  • Mentor and guide junior engineers by providing technical support, fostering professional development, and facilitating knowledge transfer.
  • Lead cross-functional teams to drive continuous improvement initiatives and achieve operational goals.
  • Develop and implement strategic plans for process improvements and new technology integration.
  • Collaborate with senior management to align engineering activities with business objectives.
  • Monitor industry trends and advancements to ensure the company remains competitive and innovative.
  • Comply with EHS, ISO13485, GMP, FDA regulations, and GDP requirements.
  • Any other project or duties as assigned.

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.
  • Availability to travel if required.


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