Manufacturing Engineer II

Boston Scientific Corporation; Penang; Presencial; MYR 90 000 - 130 000; Tempo integral

Resumo da oferta

Boston Scientific Corporation in Penang, Malaysia, is seeking an experienced engineer to support the development, validation, and optimization of manufacturing processes and equipment. The role involves collaboration with R&D and production teams to transfer new products into commercial production while applying Lean methods to reduce waste.

Under supervision, you will contribute to DFSS/DMAIC activities, calibration management, and quality system compliance, with mentorship for advanced

Qualificações

• Bachelor's degree in Engineering or related field.
• 3–5 years of working experience in a related field.
• Demonstrates basic technical expertise on process/product technologies.

Responsabilidades

• Support design, optimization, validation and troubleshooting of process and product technologies.
• Provide input to equipment/vendor selection and development for new or upgraded equipment.
• Assist with selection, design and development of new equipment, tooling and materials.
• Support validation activities including FMEA, Validation Plans, protocols and reports.
• Assist in writing and releasing process validation documents and coordinating validation builds.
• Ensure compliance with quality systems and regulatory requirements.

Conhecimentos

Lean methodologies

Formação académica

Bachelor's Degree in Engineering

Ferramentas

PFMEA

Calibration Management System

Descrição da oferta de emprego

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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

Candidate required possess at least Bachelor's Degree in Engineering. Preferable in mechanical, Chemical or biomedical.

Required at least 3 ~ 5 years of working experience in related field.

Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.

Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

This is additional headcount for expansion.

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.

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