Manufacturing Engineer

Boston Scientific Gruppe; Penang; On-site; MYR 40,000 - 60,000; Full time

Job summary

A global medical technology leader in Penang is seeking a Medical Device Engineer to support design, optimization, and validation of process and product technologies. Candidates should hold a degree in Engineering and have 3-5 years of experience in manufacturing or process engineering, preferably in the medical device sector. This role involves technical support, process validation, and calibration tasks, with an emphasis on problem-solving and analytical skills.

Qualifications

• 3-5 years of experience in manufacturing/process engineering, preferably in the medical device industry.
• Experience in product transfer will be an added advantage.

Responsibilities

• Demonstrates basic technical expertise on process/product technologies.
• Under supervisory direction, provides input to equipment engineering.
• Demonstrates good working knowledge of DFSS/DMAIC tools.
• Supports the development and execution of experimentation and testing.
• Supports the introduction of new processes, equipment, and materials.
• Demonstrates application of Lean methodologies.
• Supports writing and release of process validation documentation.
• Provides equipment calibration services and supports calibration group.

Skills

Problem Solving

Analytical skills

Project management

Critical thinking

New Product Introduction (NPI)

People leadership

Education

Minimum Degree in Engineering

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, analyzes 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, analyzes 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 set 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.

Requirements

• Minimum Degree in Engineering
• 3-5 years of experience in manufacturing / process engineering. Prior experience in the medical device industry is preferred.
• Required skills: Problem Solving, analytical skill, project management, critical thinking, NPI, people leadership
• Experience in product transfer will be added advantage.

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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