Manufacturing Engineer

Boston Scientific; Seberang Perai; On-site; MYR 35,000 - 65,000; Full time

Job summary

An established industry player in medical technology seeks a Calibration Engineer to enhance manufacturing processes and ensure compliance with quality regulations. In this dynamic role, you will collaborate closely with R&D and Manufacturing teams to develop innovative solutions that meet rigorous standards. You will leverage your technical expertise to troubleshoot and optimize processes, while also managing calibration systems and supporting audits. This is an exciting opportunity to make a meaningful impact in a company that values innovation and quality in healthcare.

Qualifications

• Experience with process optimization and validation techniques.
• Familiarity with Lean and Six Sigma methodologies.

Responsibilities

• Support design, optimization, and troubleshooting of manufacturing processes.
• Assist in writing and releasing process validation documentation.

Skills

Lean methodologies

DFSS/DMAIC tools

Technical expertise in process/product technologies

Troubleshooting skills

Education

Bachelor's degree in Engineering or related field

Tools

Calibration equipment

Validation documentation tools

Job description

Purpose Statement
Under supervisory direction, works closely with R&D and Manufacturing to develop robust, capable, cost-effective, and safe manufacturing processes, equipment, materials, and products. Supports the efficient transfer of new products and processes into commercial production.

About Us
As a global medical technology leader for over 40 years, Boston Scientific (NYSE: BSX) aims to transform lives through innovative medical solutions that improve patient health. If you want to make a meaningful difference worldwide and locally, this is the place to do it.

Key Responsibilities

1. Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation, and troubleshooting.
2. Provides input to Equipment engineering or external vendors in selecting, designing, and developing new or upgraded equipment, tooling, and materials.
3. Applies DFSS/DMAIC tools in process characterization, optimization, and troubleshooting, with mentor assistance.
4. Supports experimentation and testing to characterize, optimize, and troubleshoot processes and equipment, analyzing results to draw technical conclusions.
5. Assists in introducing new processes, equipment, and materials, including installation, calibration, EHS assessments, debugging, and documentation.
6. Uses Lean methodologies and process improvement tools to identify waste and develop cost-effective equipment and processes, with mentor guidance.
7. Supports validation techniques, PFMEAs, and regulatory requirements, aiding in validation of equipment and processes.
8. Assists in writing and releasing process validation documentation such as FMEAs, Validation Plans, protocols, and reports.
9. Supports execution and documentation of validation builds, testing validation units, and analyzing results.
10. Ensures compliance with quality system regulations.

Calibration Engineering Role Specifics:

1. Provides calibration services to meet company objectives, ensuring measurement traceability.
2. Serves as Technical SME for Calibration and supports internal/external audits.
3. Manages Calibration System and performs calibration functions daily.
4. Researches and acquires new standards and equipment, providing justifications and cost analysis.
5. Develops calibration reports and procedures, training technicians on new procedures.
6. Supports calibration lab operations, environmental controls, and new technologies.
7. Assists in departmental budgeting and communicates calibration status to management.
8. Maintains quality and drives standard work in calibration activities.