Senior Equipment Engineer

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

Job summary

Boston Scientific in Penang, Malaysia, seeks an experienced Equipment Engineer to develop and qualify manufacturing and test equipment for medical devices. You will lead design, selection of components, and documentation to FDA/QSR standards.

The role requires a Bachelor’s in engineering and 8 years of equipment engineering experience, with proven product transfers and cross-site collaboration. You will mentor technicians and drive continuous improvement.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, or related).
• 8+ years in equipment engineering with proven transfers and qualifications.
• Experience in matrix organizations and cross-site collaboration.

Responsibilities

• Participates on project teams to develop specifications and provide estimates for system designs.
• Leads and liaises with external design companies to provide engineering solutions.
• Reviews mechanical designs and drawings using parametric modelling and FEA software.
• Coordinates project designs, estimates, costs, and schedules to meet delivery requirements.
• Prepares reports to communicate status and results.
• Leads teams of Designers, Engineers and Technicians in design, assembly and debugging.
• Designs pneumatic systems and selects components; identifies electrical and control needs.
• Assist with FDA/QSR equipment documents and software validations.

Skills

Mechanical design

Project management

Root cause analysis

Technical documentation

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.

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

Participates on project teams to develop clear specifications, evaluates the feasibility of concepts, and provides formal estimates for system designs. Leads and liaises with external design companies to provide engineering solutions for BSC.

• 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.