Global Process Engineering Leader – Medical Devices

Intuitive; Penang; On-site; MYR 420,000 - 640,000; Full time

Job summary

Intuitive's Penang, Malaysia plant seeks a Sr. Manager to define and execute the strategic vision for Process Engineering. You will lead the instruments and accessories manufacturing, drive continuous improvement, and oversee validation and qualification of processes and equipment.

You will build and mentor a high-performing team, manage KPIs, and collaborate with production, planning, procurement, and supplier functions to achieve manufacturing excellence. International travel is expected.

Qualifications

• Lead Process Engineering team in Penang for instruments and accessories worldwide.
• Manage multi-year capacity roadmap including product transfers, line duplications, and automation.
• Oversee validation and qualification of equipment and processes per medical device standards.
• Hire, train, mentor, and evaluate personnel; cultivate high-performance culture.
• Define and monitor KPIs for performance across plants using data analytics.
• Collaborate with plant leadership across production, planning, procurement, scheduling, and suppliers.
• Travel to Intuitive plants globally as needed (up to 50% Year 1).

Responsibilities

• Lead Process Engineering team (Manufacturing Engineering and Equipment Engineering) in Penang, Malaysia enabling production and development of Instruments and Accessories for use in robotic procedures worldwide
• Maintain multi-year capacity roadmap including product transfers, line duplications, factory automation, and efficiency improvements
• Oversee validation and qualification of manufacturing equipment and processes in compliance with medical device standards (DQ/IQ/OQ/PQ/PPQ)
• Maintain compliance with medical device quality system including CAPA, material disposition, audits and ECOs
• Hire, train, mentor and evaluate personnel to ensure efficient operation of process engineering functions.
• Define, measure, and maintain KPIs for critical performance metrics across plants using data analytics tools and dashboards
• Travel to Intuitive plants globally (up to 50% Year 1, up to 20% future years)

Skills

Process Engineering

Manufacturing Engineering

Leadership

Project Management

Validation & Qualification

Data Analytics

Medical Devices

Education

BS degree in Engineering

Job description

Intuitive's Penang, Malaysia plant seeks a Sr. Manager to define and execute the strategic vision for Process Engineering. You will lead the instruments and accessories manufacturing, drive continuous improvement, and oversee validation and qualification of processes and equipment.

You will build and mentor a high-performing team, manage KPIs, and collaborate with production, planning, procurement, and supplier functions to achieve manufacturing excellence. International travel is expected.