Process Development Engineer II: NPI, Validation & Lean

Boston Scientific Corporation; Penang; On-site; MYR 60,000 - 80,000; Full time

Job summary

Boston Scientific Corporation in Penang, Malaysia, is seeking a manufacturing engineer with experience in process technologies, validation, and equipment qualification. The role collaborates with R&D, manufacturing, and vendors to ensure robust and cost-effective production transfers.

The ideal candidate will have 2–5 years in manufacturing, familiarity with Lean Six Sigma, and experience with new product introductions, process validation, and cross-functional teams in a medical device setting.

Qualifications

• Bachelor’s degree in engineering is required.
• 2–5 years of manufacturing experience.
• Lean Six Sigma, Quality, Validation, or Project Management certifications are a plus.
• Experience with NPI, product transfers, process validation, or equipment qualification is advantageous.

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 vendors in the selection, design & development of new or upgraded equipment, tooling and materials.
• Demonstrates good working knowledge of DFSS/DMAIC tools and applies these tools in 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 and analyzes test results leading to technical resolutions.
• Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment, debugging, and related process and quality system documentation.

Skills

Analytical thinking

Problem-solving

Communication

Teamwork

Cross-functional

Education

Bachelor's degree in Engineering

Tools

Vision inspection systems

Automated inspection equipment

Machine vision technologies

Job description

Boston Scientific Corporation in Penang, Malaysia, is seeking a manufacturing engineer with experience in process technologies, validation, and equipment qualification. The role collaborates with R&D, manufacturing, and vendors to ensure robust and cost-effective production transfers.

The ideal candidate will have 2–5 years in manufacturing, familiarity with Lean Six Sigma, and experience with new product introductions, process validation, and cross-functional teams in a medical device setting.