Process Development Engineer II

Boston Scientific Corporation; Penang; Vor Ort; MYR 60.000 - 80.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical thinking

Problem-solving

Communication

Teamwork

Cross-functional

Ausbildung

Bachelor's degree in Engineering

Tools

Vision inspection systems

Automated inspection equipment

Machine vision technologies

Jobbeschreibung

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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.