Senior Manufacturing Process Engineer, Medical Devices

Radiometer; Singapore; Vor Ort; SGD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health care benefits

Paid time off

Zusammenfassung

Leica Microsystems, a Danaher operating company, is seeking a Principal/Senior Manufacturing Process Engineer to establish and optimize medical device assembly processes in Singapore. The role focuses on safety, quality, delivery, and regulatory compliance, reporting to the Director of Project & Engineering.

You will support process validation, production issue resolution, controlled documentation, and continuous improvement within the Process Engineering team on-site in Singapore.

Qualifikationen

• Bachelor's degree in Mechatronics or related engineering discipline.
• 5+ years in Lean manufacturing or production; 3+ years in medical devices.
• Knowledge of medical device quality and ISO 13485 requirements.
• Experience with process validation, FMEA, DoE, and root-cause analysis.
• Working knowledge of SAP and controlled documentation.
• Plus: audits, inspection readiness, and device history record accuracy.
• Experience leading corrective actions and supplier quality investigations.
• Training production staff and deploying Lean/Danaher SBS standard work.

Aufgaben

• Improve manufacturing performance by tracking yield, process capability, productivity, MRB trends, and recurring issues.
• Provide day-to-day process and product engineering support after design transfer.
• Plan, execute, document, and maintain qualification and validation of processes, tools, and equipment.
• Coordinate engineering changes and maintain documentation, training, SAP data, and risk assessments.
• Develop standard work and manufacturing playbooks using Lean and SBS tools.

Kenntnisse

Lean manufacturing

Process validation

Root cause analysis

New product transfer

SAP

Ausbildung

Bachelor's degree in Mechatronics or related engineering

Tools

SAP

Process validation tools

Jobbeschreibung

Leica Microsystems, a Danaher operating company, is seeking a Principal/Senior Manufacturing Process Engineer to establish and optimize medical device assembly processes in Singapore. The role focuses on safety, quality, delivery, and regulatory compliance, reporting to the Director of Project & Engineering.

You will support process validation, production issue resolution, controlled documentation, and continuous improvement within the Process Engineering team on-site in Singapore.