Manufacturing Engineer (Junior)

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a Calibration Engineer to support development, qualification and maintenance of robust manufacturing processes and equipment.

Under supervision, you will implement calibration practices, assist in validation plans and reports, and mentor technicians. A Bachelor’s in Engineering with 3–5 years’ relevant experience is required and the role involves hands-on calibration work in a manufacturing setting.

Qualifications

• Bachelor's degree in engineering; mechanical/ chemical/ biomedical preferred.
• 3–5 years of relevant experience in calibration/ manufacturing.
• Demonstrates basic technical expertise to support design, optimization, validation and troubleshooting.

Responsibilities

• Provide calibration services and ensure traceability to standards.
• Support equipment, tooling, and material selection and development.
• Assist in validation activities, PFMEA, validation plans and reports.
• Develop calibration procedures and train technicians on new procedures.

Skills

Calibration

Process validation

Technical troubleshooting

Education

Bachelor's Degree in Engineering

Tools

Calibration Management System

Job description

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.

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.