Process Development Engineer II

Boston Scientific; George Town; On-site; MYR 67,000 - 123,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking an engineering professional to develop robust manufacturing processes, support transfer of new products into production, and ensure cost-effective, safe operations across equipment and materials.

You will apply DFSS/DMAIC methods, assist in process validation, and work under supervision with cross-functional teams to deliver timely, quality results.

Qualifications

• Bachelor's degree in engineering.
• Minimum 2-5 years of relevant experience in a manufacturing environment.
• Experience leading or supporting process improvement, quality improvement, or cost reduction projects.
• Professional certifications such as Lean Six Sigma or related certifications are an added advantage.
• Experience supporting NPI, product transfers, process validation, or equipment qualifications is an added advantage.
• Experience with vision inspection systems, automated inspection equipment, or machine vision technologies is an added advantage.
• Strong analytical, problem-solving, communication, and teamwork skills.

Responsibilities

• Demonstrates basic technical expertise on process/product technologies to support design, optimisation, validation and troubleshooting.
• Provides input to equipment engineering or external vendors in selection, design and development of new or upgraded equipment, tooling and materials.
• Applies DFSS/DMAIC tools in characterization, optimization and troubleshooting with mentor assistance.
• Supports development and execution of experiments and testing to characterize and optimize processes and equipment.
• Supports introduction of new processes, equipment and materials including documentation and validation requirements.
• Demonstrates good working knowledge of Lean methodologies and process improvement tools to remove waste and improve efficiency.
• Assists with process and equipment validation techniques, PFMEA and regulatory requirements and validates equipment/processes timely.
• Writes and releases process validation documentation including FMEA's, Validation Plans, protocols and reports.

Skills

Analytical thinking

Problem solving

Communication

Teamwork

Education

Bachelor's Degree in Engineering

Tools

DMAIC

DFSS

Process Validation

Job description

Purpose Statement:

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 Responsibilities:

• Demonstrates basic technical expertise on process/product technologies to support design, optimisation, 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 characterization, 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.

Job Requirements:

• Bachelor's Degree in any Engineering discipline.
• Minimum 2-5 years of relevant experience in a manufacturing environment.
• Experience leading or supporting process improvement, quality improvement, or cost reduction projects.
• Professional certifications such as Lean Six Sigma, Quality, Validation, Project Management, or related certifications are an added advantage.
• Experience supporting New Product Introduction (NPI), product transfers, process validation, or equipment qualifications is an added advantage.
• Experience with vision inspection systems, automated inspection equipment, or machine vision technologies will be an added advantage.
• Strong analytical, problem-solving, communication, and teamwork skills.
• Ability to work effectively in a cross-functional environment and manage multiple priorities.
• Experience in the medical device industry is preferred.

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.