Equipment Eng - P3

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. 4.2 View all jobs

• Participates on project teams to develop clear specifications, evaluates the feasibility of concepts, and provides formal estimates for mechanical designs.
• Evaluates the 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.

Key Responsibilities

• Participates on project teams to develop clear specifications, evaluates the feasibility of concepts, and provides formal estimates for mechanical designs.
• Evaluates the 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.

Requirements

• Degree in Engineering, preferably 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.

Required Skills

• Equipment qualification and validation (IQ/OQ/PQ, IVOT, EQR).
• Regulatory compliance requirements.
• Preventive Maintenance (PM) optimization and reliability-centered maintenance.
• Smart Factory, Industry 4.0, MES, and data-driven equipment monitoring.
• Equipment troubleshooting and root cause analysis.
• Automation and manufacturing equipment engineering.
• Project management and equipment lifecycle management.
• Vendor and contractor coordination for equipment procurement and installation.
• CAD modelling and mechanical design.
• Pneumatic and hydraulic systems.
• Equipment Installation & Qualification support.
• Strong communication and cross-functional collaboration skills.
• Technical documentation and report preparation.
• Willingness to travel as required.

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

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