Lead Equipment Engineer: Automation & Validation

Boston Scientific Gruppe; Malaysia; On-site; MYR 180,000 - 240,000; Full time

Job summary

Boston Scientific is seeking an experienced Senior Equipment Engineer to lead the design, integration, and qualification of automated manufacturing equipment in a regulated environment.

You will drive cross-functional projects across Designers, Engineers and Technicians, mentor maintenance staff, and deliver initiatives that improve equipment uptime, MTTR, and process reliability while ensuring compliance with FDA/QSR requirements.

Qualifications

• Bachelor’s Degree in Engineering or related engineering discipline.
• Minimum 9 years of experience in equipment engineering and manufacturing operations, including automation, equipment integration, qualification, troubleshooting, and continuous improvement.
• Experience in factory integration, equipment reliability, validation, and automation.
• Experience in manufacturing equipment development, sustaining, and optimization in a regulated manufacturing environment.
• Proven ability to lead projects, manage priorities, and drive technical solutions across cross-functional teams.

Responsibilities

• Develops clear specifications, evaluates feasibility, and provides formal estimates for system designs.
• Leads cross‑functional teams to meet delivery requirements and liaises with external design companies.
• Creates and reviews mechanical designs and detail drawings using parametric modelling and FEA software.
• Coordinates, monitors, and documents project designs, estimates, and costs; monitors schedule and scope changes to meet delivery requirements.
• Prepares standard reports/documentation to communicate status and results.
• Leads project teams that include Designers, Engineers and Technicians in design, assembly, and debugging of equipment; champions best practices.
• Selects materials and coatings; manages spares usage.
• Designs pneumatic systems and automated control components."
• Assists with completing required FDA/QSR equipment documents including specifications, software validations and qualifications.
• Opportunity to learn or implement industrial controls software.
• Influences and defines functional procedures through cross-functional engineering initiatives.
• Provides training to ensure proper operation and maintenance of equipment.
• Incident Management: manages equipment failures, outlines impact, recovery plan, and resources required.
• Generates weekly/monthly metrics on downtime, MTTR, MTBF, cost, improvement activity, PM compliance, and resource management.
• Ensures work carried out as part of Primo is per procedures; drives continuous process improvement.
• Continuously up-skills Maintenance Techs using TSG and creation of setup and maintenance documents.

Skills

Robotics

Vision systems

MES Integration

Root cause analysis

Project management

Technical documentation

Cross-functional collaboration

Communication

Equipment reliability

Mechanical design

FEA

Pneumatic design

Automated control systems

Education

Bachelor’s Degree in Engineering

Job description

Boston Scientific is seeking an experienced Senior Equipment Engineer to lead the design, integration, and qualification of automated manufacturing equipment in a regulated environment.

You will drive cross-functional projects across Designers, Engineers and Technicians, mentor maintenance staff, and deliver initiatives that improve equipment uptime, MTTR, and process reliability while ensuring compliance with FDA/QSR requirements.