Process Development Engineer

Boston Scientific; George Town; On-site; MYR 60,000 - 100,000; Full time

Job summary

A leading medical technology company is seeking a process development engineer to collaborate with R&D and Manufacturing. This role involves technical expertise in process design, validation, and improvements, ensuring compliance with safety and quality regulations. The ideal candidate will possess a Bachelor's degree in engineering, with significant experience in process development.

Qualifications

• 5-7 years of experience in process or process development.
• Medical background is an added advantage.

Responsibilities

• Demonstrates strong technical expertise on process/product technologies.
• Coordinates the introduction of new processes, equipment, and materials.
• Utilizes Lean methodologies and process improvement tools.

Skills

Process development

New product introduction

Process improvement

Statistical analysis

Education

Bachelor's degree in engineering or related field

Job description

Purpose Statement

Works closely with R&D and Manufacturing in the development of robust, capable, cost-effective, and safe manufacturing processes, equipment, materials, and products. Supports the efficient transfer of new products and processes into commercial production.

Job Responsibilities

• Demonstrates strong technical expertise on process/product technologies to support selection, design, optimization, validation, troubleshooting, and mentors engineers and technicians in problem resolution related to these technologies.
• Collaborates with Equipment Engineering or external vendors in the selection, design, and development of new or upgraded equipment, tooling, and materials.
• Applies knowledge of DFSS/DMAIC tools in characterization, optimization, and troubleshooting of process equipment and technology performance.
• Leads experimentation and testing to characterize, optimize, and troubleshoot key processes and equipment, analyzing results to draw effective technical conclusions.
• Coordinates the introduction of new processes, equipment, and materials, including installation, calibration, EHS assessment, debugging, and documentation such as work instructions.
• Utilizes Lean methodologies and process improvement tools to identify waste and develop efficient, cost-effective processes and equipment.
• Applies validation techniques, PFMEAs, and regulatory requirements for efficient and timely validation of equipment and processes.
• Prepares and releases process validation documentation, including FMEAs, validation plans, protocols, and reports.
• Coordinates validation activities, testing, and documentation, analyzing validation results for reporting.
• Supervises technicians, managing their technical development and daily tasks.
• Maintains a primary commitment to patient safety and product quality, ensuring team compliance and training.
• Ensures adherence to all relevant quality system regulations.

Job Requirements

• Bachelor's degree in engineering or related field.
• 5-7 years of experience in process or process development.
• Skills in process development, new product introduction, process improvement, and statistical analysis.
• Medical background is an added advantage.

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. Join us to make a difference worldwide and locally.