Senior Equipment Engineer – CAD & Automation Lead

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 150,000 - 240,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a seasoned Equipment Engineer to lead mechanical design, electrical integration, and qualification activities for medical devices.

You will collaborate with Designers, Engineers and Technicians, develop CAD drawings, specify components, and ensure compliance with FDA/QSR and regulatory standards. This role also focuses on preventive maintenance, reliability improvement, and project delivery.

Qualifications

• Degree in Electrical/Electronics engineering.
• Minimum 6 years of experience in equipment engineering, automation, or manufacturing environments.
• Experience in equipment troubleshooting, preventive maintenance, reliability improvement, root cause analysis, and continuous improvement projects.
• Strong knowledge of electrical and mechanical engineering principles.
• Experience supporting manufacturing equipment installation, qualification, validation, and sustaining activities.
• Experience managing equipment-related projects, upgrades, relocations, and capacity expansion initiatives.

Responsibilities

• Participates on project teams to develop clear specifications, evaluates feasibility of concepts, and provides formal estimates for mechanical designs.
• Evaluates feasibility of concepts and provides estimates for mechanical designs.
• Creates mechanical designs and detail drawings utilizing CAD modelling software per department standards development tools and procedures.
• Procures standard machine parts and custom fabricated tooling. Selects materials and coatings for use in automated equipment and tooling.
• Coordinates, monitors and documents project designs, estimates, and costs during project execution.
• Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements.
• Prepares standard reports/documentation to communicate status and results.
• Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of equipment and upgrades.
• Designs pneumatic and hydraulic systems and specifies basic pneumatic and hydraulic components.
• Assists in defining basic electrical component and automated control requirements.
• Creates, reviews, and approves required FDA/QSR equipment documents including specifications and qualifications. Support Equipment Installation & Qualification and Manages spares usage.
• Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.
• Generates weekly and Monthly metrics on Equipment downtime, MTTR, MTBF, Cost, Improvement activity, PM compliance, and resource management.
• Ensure Work carried out as part of Primo is as per procedures – Continue to improve this process.
• Continuously drives the ‘up-skill’ of Maintenance Techs using TSG and creation of set up and maintenance documents.

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a seasoned Equipment Engineer to lead mechanical design, electrical integration, and qualification activities for medical devices.

You will collaborate with Designers, Engineers and Technicians, develop CAD drawings, specify components, and ensure compliance with FDA/QSR and regulatory standards. This role also focuses on preventive maintenance, reliability improvement, and project delivery.