Process Development R&D Engineer

Biosensors Interventional Technologies Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biomedical engineering company in Singapore seeks an engineer for roles in product improvement and engineering projects. The successful candidate will perform risk analysis, equipment qualification, and optimize processes to enhance product quality. A degree in engineering is required, alongside good communication skills and experience in manufacturing processes. This position offers a dynamic work environment focused on innovation in biomedical technologies.

Qualifications

• Minimum a Bachelor Degree in relevant engineering disciplines.
• Good mechanical or material aptitude and knowledge.
• Experience in manufacturing processes and cGMP standards.
• Clean room/environment control experience is preferred.
• Ability to work with mathematical concepts.

Responsibilities

• Responsible for engineering activities in product improvement projects.
• Perform risk analysis and manage equipment qualification.
• Ensure project implementation meets schedule and budget.
• Optimize process parameters for product quality.
• Provide training for operators.

Skills

Mechanical aptitude

Knowledge of cGMP manufacturing

Lean manufacturing experience

Excellent communication skills

Education

Bachelor Degree in Mechanical/Industrial/Manufacturing/Biomedical Engineering

Job description

Summary

• To be responsible for engineering activities in product improvement/engineering projects; performs engineering analysis, equipment and process set up, carry out risk assessments and validations as well as production implementation for completed projects.

Responsibilities

• Participate in product improvement/engineering projects, and responsible for engineering activities.
• Perform risk analysis (FMEA) to define process flow and control plan.
• Perform equipment qualification and process validation for product improvement/engineering projects.
• Ensure projects are implemented in line with the schedule and budget.
• Optimize new/improved process parameters to further improve product quality and the overall equipment effectiveness.
• Explore new process to improve product quality or productivity.
• Be responsible for the successful transfer of new/improved process/methodologies into the production with good process margins and inline controls.
• Involved in hands‑on execution of manufacturing operations.
• Provide operational training for operators or related personnel.
• Manage administrative duties as well as ad‑hoc projects assigned by immediate superior.

Requirements

• Minimum a Bachelor Degree in Mechanical/Industrial/Manufacturing/Biomedical Engineering related disciplines or equivalent.
• Good mechanical or material aptitude and knowledge.
• Good experience of manufacturing process and cGMP manufacturing.
• Experience of operational management and lean manufacturing.
• Clean room/environment control experience.
• 2 years of overall work experience would be added an advantage.
• Excellent speaking & writing skills and able to communicate with vendors in Asian countries.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to write professional reports, business correspondence, and procedure manuals.