Principal / Senior Manufacturing Process Engineer (Lifecycle Management)

About the role

Leica Microsystems, a Danaher operating company, is hiring a Principal / Senior Manufacturing Process Engineer for its Process Engineering team in Singapore. The role is on-site and reports to the Director, Project & Engineering. It covers the establishment, sustenance and optimisation of medical device assembly processes to improve safety, quality, delivery, productivity, cost and regulatory compliance, with support across process validation, production issues, engineering changes, controlled documentation, training and continuous improvement.

Key responsibilities

• Monitor first pass yield, process capability, productivity, material review board trends and recurring production issues, then implement sustainable corrective and preventive actions.
• Provide day-to-day process and product engineering support after new product design transfer, including troubleshooting, containment, root-cause analysis, complaint investigation and resolution of manufacturing and product issues.
• Plan, execute, document and maintain qualification and validation of manufacturing processes, tools, fixtures and equipment, including preventive maintenance and process requalification.
• Coordinate engineering changes and maintain production readiness across controlled documents, materials, tooling, training, SAP data, process risk assessments, control plans, routings and work instructions.
• Develop and sustain standard work and manufacturing playbooks using Lean and Danaher Business System tools, and support supplier qualification, first article testing, audits, inspection readiness and compliance improvement.

Required profile

• Bachelor's degree in Mechatronics, Electrical, Electronics, Industrial, Production, Mechanical Engineering or a related engineering discipline.
• Minimum 5 years of related experience in a Lean manufacturing or production environment, including at least 3 years in medical device manufacturing.
• Knowledge of medical device quality and regulatory requirements, including ISO 13485 and Medical Device Single Audit Program requirements.
• Experience with manufacturing process validation, jig and fixture design, Failure Mode and Effects Analysis, Design of Experiments and structured root-cause problem solving.

Required skills

• Working knowledge of SAP and controlled manufacturing documentation such as process risk assessments, control plans, routings, inspection instructions and work instructions.
• A plus: audit and inspection readiness support, complaint, warranty, CAPA and supplier quality investigations, and production training and Lean/Danaher Business System standard work deployment.