Manufacturing Engineer II: Process Validation & Improvement

Boston Scientific; George Town; On-site; MYR 67,000 - 112,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, seeks a Calibration Engineer to support calibration and validation of equipment and processes under supervision. You will coordinate with R&D and Manufacturing to ensure measurement traceability and compliant documentation, including calibration procedures and reports.

You will apply DFSS/DMAIC tools, Lean methodologies and PFMEA concepts to optimize calibration workflows, support new equipment integration, and help drive standard work and quality

Qualifications

• Bachelor's Degree in Engineering (Mechanical/Chemical/Biomedical preferred).
• 3-5 years of relevant experience in related field.
• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.
• Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

Responsibilities

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, 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 characterisation, optimization and troubleshooting of processes and equipment.
• 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.
• Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.
• With mentor assistance ensures compliance with all the regulations governing the quality systems.
• Drive "Standard Work" in all aspect of Calibration activity.

Skills

DFSS/ DMAIC tools

Lean methodologies

Process validation

Calibration concepts

Quality systems

Analytical reasoning

Education

Bachelor's Degree in Engineering (Mechanical/Chemical/Biomedical preferred)

Tools

Calibration Management System

Job description

Boston Scientific in Penang, Malaysia, seeks a Calibration Engineer to support calibration and validation of equipment and processes under supervision. You will coordinate with R&D and Manufacturing to ensure measurement traceability and compliant documentation, including calibration procedures and reports.

You will apply DFSS/DMAIC tools, Lean methodologies and PFMEA concepts to optimize calibration workflows, support new equipment integration, and help drive standard work and quality