Principal Mfg Process Engineer, Medical Devices Lifecycle

leica instruments (singapore) pte limited; Singapore; Sur place; SGD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Benefits program

Résumé du poste

Leica Microsystems in Singapore is seeking a Principal/Senior Manufacturing Process Engineer to establish, sustain, and optimize medical device assembly processes to improve safety, quality, delivery, productivity, cost, and regulatory compliance.

The role provides manufacturing engineering support across process validation, production issue resolution, engineering changes, controlled documentation, training, and continuous improvement.

Qualifications

• Bachelor's degree in engineering required.
• Minimum 5 years in Lean manufacturing/production; 3+ years in medical devices.
• Knowledge of ISO 13485 and MDSAP requirements.
• Experience with process validation, jig/fixture design, FMEA, DoE, root-cause analysis.
• Working knowledge of SAP and controlled manufacturing documentation.

Responsabilités

• Improve medical device manufacturing performance by monitoring KPIs and implementing corrective actions.
• Provide day-to-day process and product engineering support after design transfer and for manufacturing issues.
• Plan, execute, document, and maintain qualification/validation of processes, tools, and equipment.
• Coordinate engineering changes and maintain production readiness across controlled docs and SAP data.
• Develop standard work and Lean playbooks; support supplier qualification, audits, and compliance activities.

Connaissances

Lean manufacturing

Root-cause analysis

Process improvement

Cross-functional collaboration

Production troubleshooting

Formation

Bachelor's degree in engineering (Mechatronics/Electrical/Electronics/Industrial/Production/Mechanical)

Outils

SAP

Description du poste

Leica Microsystems in Singapore is seeking a Principal/Senior Manufacturing Process Engineer to establish, sustain, and optimize medical device assembly processes to improve safety, quality, delivery, productivity, cost, and regulatory compliance.

The role provides manufacturing engineering support across process validation, production issue resolution, engineering changes, controlled documentation, training, and continuous improvement.