Process Development Engineer II

Boston Scientific Gruppe; Penang; Presencial; MYR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Boston Scientific Gruppe in Penang is seeking a Process Engineer to help develop and optimize robust, cost-effective manufacturing processes for safe medical devices.

Under supervision, you will collaborate with R&D and Manufacturing, apply DFSS/DMAIC methods, support equipment qualification and process validation, and contribute to continuous improvement projects across the value stream.

Formación

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

Responsabilidades

• Demonstrates basic technical expertise to support design, optimisation, validation and troubleshooting.
• Provides input to equipment/vendor teams for new or upgraded equipment, tooling and materials.
• Applies DFSS/DMAIC tools with mentor assistance to characterize and optimize performance.
• Supports experimentation and testing to characterize and troubleshoot processes and equipment.
• Supports introduction of new processes/equipment/materials including installation, calibration, EHS assessment, and documentation.
• Applies Lean methodologies and process-improvement tools to identify waste and improve efficiency.
• Supports process and equipment validation techniques, PFMEA and regulatory requirements.
• Writes and releases process validation documentation including FMEA, validation plans, protocols and reports.

Conocimientos

Lean Six Sigma

Process engineering

Analytical skills

Problem-solving

Teamwork

Communication

Educación

Bachelor's Degree in Engineering

Herramientas

Vision inspection systems

Machine vision

Automated inspection equipment

Descripción del empleo

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.

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