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Boston Scientific Gruppe in Penang, Malaysia is looking for an engineer to develop and optimize manufacturing equipment for medical devices. Responsibilities include leading project teams, driving process improvements, and ensuring compliance with FDA/QSR standards.
The ideal candidate has a Bachelor's Degree in Mechanical Engineering and 2–5 years of industry experience. The role offers opportunities for professional growth and contributions to process optimization initiatives.
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.
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. Completes project deliverables and monitors project schedule and scope changes to assure the team can meet delivery requirements.
Prepares standard reports and documentation to communicate status and results.
Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debugging of equipment. Provides 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.
Assists with completing required FDA/QSR equipment documents including specifications, software validations and qualifications.
Opens 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.
Ensures work carried out as part of Primo is as per procedures – continuously improves this process.
Continuously drives the ‘up‑skill’ of maintenance techs using TSG and creation of set up and maintenance documents.