Senior Equipment Engineer

Cari; Penang; On-site; MYR 180,000 - 300,000; Full time

Job summary

Boston Scientific is seeking an experienced Equipment Engineer to develop and support complex manufacturing and test equipment for medical devices. The role involves leading cross-functional teams, reviewing designs, and ensuring compliance with specifications and validations.

The position requires strong project management, diagnostics, and documentation skills, with experience in FDA/QSR processes and equipment qualification.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 8 years of experience in equipment engineering.
• Proven track record in equipment transfer and qualification.
• Strong project management and documentation skills.
• Experience in matrix organizations and global teams.

Responsibilities

• Creates and reviews mechanical designs and drawings using parametric modelling and FEA.
• Coordinates project designs, estimates, costs, and schedules to meet delivery requirements.
• Leads teams in design, assembly, and debugging of equipment.
• Selects materials and coatings for automated equipment and tooling.
• Designs pneumatic systems and identifies control requirements.
• Assist with FDA/QSR equipment documents including specifications and validations.
• Influences cross-functional procedures and trains staff as needed.
• Generates weekly and monthly metrics on downtime and performance.

Skills

Project management

Root cause analysis

Cross-site collaboration

Education

Bachelor’s Degree in Engineering

Job description

Purpose Statement

Develops new equipment and tooling used in the development and production of medical devices. Independently or as a member of a team; develops specifications, designs, plans and builds complex manufacturing and test equipment.

Job Responsibilities

• Creates and reviews mechanical designs and detail drawings utilizing parametric modelling and FEA software.
• Coordinates, monitors and documents project designs, estimates, and costs. 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. Provide leadership role on championing functional best practices.
• Selects materials and coatings for use in automated equipment and tooling. Manages spares usage.
• Designs pneumatic systems and specifies pneumatic components. Identifies electrical components and automated control requirements.
• Assist 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, departmental/divisional procedures through involvement with cross-functional engineering initiatives.
• Provides training as required to ensure proper operation and maintenance of equipment.
• 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 Requirements

• Candidate required possess at least Bachelor’s Degree in Engineering (Mechanical, Manufacturing, or related field)
• Minimum 8 years of experience in equipment engineering.
• Proven track record in product transfers, equipment qualification, and equipment setup and improvement.
• Experience in working within a matrix organization and cross-site collaboration.
• Strong project management and technical documentation skills.
• Proficient in equipment qualification protocol/report writing (ESQ).
• Skilled in root cause analysis and process & equipment improvement methodologies.
• Effective communication and stakeholder management across global teams.
• People manager experience in leading junior engineer or technician.

About Us

As a global medical technology leader for more than 40 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.