Boston Scientific Manufacturing Enginer 

Malaysia, Penang 

720569693

Purpose Statement:

Under supervisory direction, works closely with R&D and Manufacturing in the development of robust, capable, cost effective & safe manufacturing processes. equipment, materials and products and supports efficient and effective transfer of new products & processes into commercial production.

Job Description:

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.
• Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
• Demonstrates good working knowledge of DFSS/DMAIC tools and, with mentor assistance, applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
• Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment. and summarizes, analyses and draws conclusions from test results leading to effective technical resolution.
• Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
• With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• With mentor assistance demonstrates good working knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.
• Under supervision supports the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
• Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.
• With mentor assistance ensures compliance with all the regulations governing the quality systems.
• For individual who is assigned calibration engineering role only:
• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.
• Supporting Technical SME for Calibration group and for internal and external Audit
• Competent on Calibration Management System
• Perform calibration functions and sets day to day function for calibration group
• Supports the research and acquisition of new standards and other capital equipment, providing detailed justifications and cost analysis as required.
• Develops technical engineering reports and calibration procedures and trains department technicians on new calibration procedures.
• Provides support and guidance to calibration technicians in performing moderately complex equipment calibrations.
• Supports calibration lab needs regarding such issues as environmental control and new technologies.
• Supports Senior Metrology Engineer and Management to develop the department fiscal year budgets.
• Communicates with the Operations ME function on calibration status.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements
• Drive “Standard Work” in all aspect of Calibration activity.

Job Requirements:

• Bachelor's degree in any related engineering filed.
• Required at least 2-4 years of working experience.
• Experiences in Medical Devices Manufacturing Industry could be added advantages.
• Critical thinking and experienced in applying problem solving and process improvement methodologies such as PDCA & DMAIC.
• Poses strong collaboration skills and able work effectively with cross-functional team.