Principal/Senior Manufacturing Process Engineer (Lifecycle Management)

Location: Singapore; onsite role

Company

hirify.global is a Danaher operating company developing optical, digital, microscopy, imaging, and analysis solutions for life sciences, diagnostics, biotechnology, and surgical applications.

What you will do

• Establish, sustain, and optimize medical device assembly processes to improve safety, quality, delivery, productivity, cost, and regulatory compliance.
• Monitor First Pass Yield, process capability, productivity, Material Review Board trends, and recurring production issues, then implement corrective and preventive actions.
• Provide process and product engineering support after design transfer, including troubleshooting, containment, root-cause analysis, complaint investigation, and issue resolution.
• Plan, execute, document, and maintain qualification and validation for manufacturing processes, tools, fixtures, and equipment.
• Coordinate engineering changes and maintain production readiness across controlled documents, materials, tooling, training, SAP data, risk assessments, control plans, routings, and work instructions.
• Develop standard work and manufacturing playbooks using Lean and Danaher Business System tools while supporting supplier qualification, first article testing, audits, and inspection readiness.

Requirements

• Bachelor’s degree in Mechatronics, Electrical, Electronics, Industrial, Production, Mechanical Engineering, or a related engineering discipline.
• At least 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.
• Working knowledge of SAP and controlled manufacturing documentation, including process risk assessments, control plans, routings, inspection instructions, and production work instructions.

Nice to have

• Experience supporting audits, inspection readiness, remediation activities, and Device History Record accuracy.
• Experience leading complaint, warranty, corrective and preventive action, or supplier quality investigations.
• Experience delivering production training and deploying Lean or Danaher Business System standard work across assembly operations.

Culture & Benefits

• Culture focused on customer impact, innovation, teamwork, and continuous improvement.
• Work on projects supporting scientific discoveries and critical surgical decisions.
• Comprehensive benefits, including healthcare programs and paid time off.