My client is a leading name in the medical devices space and are going through a period of rapid expansion. They now seek an experienced Manufacturing Engineer to join them
You will be part of an innovative team developing a state-of-the-art next gen medical device
Responsibilities:
- Lead the manufacturing process and understand technical details of the automated equipment
- Sustain product and process engineering of high-volume medical devices, including product change management and process equipment validation
- Monitor and inspect performance of machinery, equipment, and tools to verify their efficiency and investigate corrective action and deficiencies to ensure product quality
- Ensure appropriate documentation of engineering change orders, validation documentation, equipment procedures and preventive maintenance plans
- Lead contract manufacturing floor support, address technical issues affecting the processes, and mitigate risks
- Collaborate with other cross-functional organizations - manufacturing, purchasing, R&D, Quality, Regulatory, Marketing
- Mentor and train other engineers, operators and mechanics
- Lead initiatives in all product manufacturing aspects such as cost reduction, quality improvement, Service/Repair, Process Improvement, Documentation.
- Design and implement fixtures and equipment to aid in device assembly.
- Perform root cause analysis and develop corrective and preventative actions for quality systems and production issues.
Requirements:
- Degree in Mechanical, Electrical, or biomedical engineering with at least 10 years' experience in medical device or related equipment manufacturing
- Strong background and technical expertise in mechanical equipment function, product complexities, design process FMECA, process validation SPC/SQC, DOE
- Robotics and Controls experience will be a plus
- Familiarity with Six Sigma, Lean Manufacturing and Minitab
- Knowledge of Engineering change management systems, operations engineering and manufacturing facilities/ systems.
- Proven capability to define, produce, test and validate automated and semi-automated work cells to increase manufacturing efficiency.
- Working knowledge of GMP and ISO regulations (Design Controls).
- Proactive, forward-thinking, able to adapt to and embrace change
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).
