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Senior Manufacturing Engineer
Senior Manufacturing EngineerBoston Scientific • George Town, Penang, Malaysia
Senior Manufacturing Engineer

Senior Manufacturing Engineer

Boston Scientific • George Town, Penang, Malaysia
30+ days ago
Job description

Key Responsibilities

  • Identify, order, and commission key process equipment to CGMP standards within the Operations Engineering Cycle to meet business objectives.
  • Serve as the engineering process owner for the area.
  • Develop and modify manufacturing documentation and procedures to support both commercial products and new product introductions, including assembly procedures and BOMs.
  • Ensure new products meet business, quality, output, and cost goals.
  • Develop and improve manufacturing processes to enhance product and process quality and output.
  • Ensure component, assembly, tooling, and supplier specifications meet requirements.
  • Perform qualification activities for products, processes, and vendors as needed.
  • Support material discrepancy review and disposition activities (MRB).
  • Build expertise in a field to become a recognized leader and apply this knowledge in leadership roles.
  • Reduce product / process defects and improve yields by solving technical problems using engineering principles.
  • Prioritize patient safety and product quality.
  • Support quality initiatives such as NCEP and CAPA to meet quality goals.
  • Maintain capacity models and plan for capital needs in collaboration with line supervisors.
  • Train cross-functional team members, including engineers, technicians, and product builders.
  • Apply project management knowledge.
  • Collaborate cross-functionally and with internal / external customers.
  • Develop expertise in BSC systems.
  • Willingness to travel internationally for projects.

For calibration engineering roles :

  • Provide calibration services ensuring measurement traceability to recognized standards.
  • Serve as SME for Calibration group, audits, and calibration management systems.
  • Perform calibration functions and manage calibration activities daily.
  • Research, recommend, and acquire new standards and equipment, including cost analysis.
  • Develop technical reports and calibration procedures; train technicians.
  • Advise on equipment selection and design accommodations for calibration.
  • Support calibration lab needs and environmental controls.
  • Assist in departmental budgeting.
  • Communicate calibration status with Operations ME.
  • Requirements

  • Degree in Engineering.
  • 9-12 years in manufacturing / process engineering, preferably in medical devices.
  • Skills : Problem solving, analytical thinking, project management, leadership, documentation, validation protocols.
  • Experience in product transfers, equipment qualification, process validation.
  • Ability to work within a matrix organization and collaborate across sites.
  • Strong project management skills and technical documentation competence.
  • Proficiency in validation protocols (IQ / OQ / PQ).
  • Expertise in root cause analysis and process improvement methodologies.
  • Excellent communication and stakeholder management skills globally.
  • Experience in product transfer is advantageous.
  • About Us

    Boston Scientific is a global medical technology leader for over 40 years, dedicated to transforming lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide.

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    Manufacturing Engineer • George Town, Penang, Malaysia

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