Medical Technology Process Specialist

5 days ago


Penang, Malaysia Boston Scientific Gruppe Full time

At Boston Scientific, we're committed to transforming lives through innovative medical solutions that improve patient health. As a Medical Technology Process Specialist, you'll play a vital role in the development of robust, capable, and cost-effective manufacturing processes, equipment, materials, and products.

Key Responsibilities
  • Develop and mentor engineers and technicians in process/product technologies, supporting selection, design, optimization, validation, and troubleshooting.
  • Liaise with Equipment Engineering or external vendors to select, design, and develop new equipment, tooling, and materials.
  • Apply DFSS/DMAIC tools for process equipment and technology performance characterization, optimization, and troubleshooting.
  • Lead experimentation and testing to characterize, optimize, and troubleshoot key processes and equipment, summarizing and analyzing results for effective technical resolution.
  • Coordinate the introduction of new processes, equipment, and materials, including installation, calibration, EHS assessment, debug, and documentation requirements.
  • Apply Lean methodologies and process improvement tools to identify and eliminate waste process steps, developing efficient and cost-effective equipment and processes.
  • Utilize process and equipment validation techniques, PFMEA's, and regulatory requirements for efficient and timely validation.
  • Complete or lead the writing and release of process validation documentation, including FMEA's, Validation Plans, protocols, and reports.
  • Coordinate execution and documentation of validation builds, testing of validation units, and compilation, analysis, and reporting of validation results.
  • Supervise technicians, managing their technical development and facilitating daily and project tasks.
  • Demonstrate primary commitment to patient safety and product quality, ensuring direct reports understand their commitment to these values.


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