Senior Process Development Engineer — Medical Devices

Boston Scientific Corporation; George Town; Presencial; MYR 180.000 - 240.000; Jornada completa

Descripción de la vacante

Boston Scientific Corporation in Malaysia’s Penang region is seeking an experienced engineer to design and develop new manufacturing processes for disposable medical devices and to lead cross-functional teams in transferring products into production.

The role requires a Six Sigma Black Belt (or equivalent), 8+ years of process development experience, and a background in regulated industries. You will ensure quality systems, documentation, and continuous improvement across projects.

Formación

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering or related engineering field.
• At least 8 years of demonstrated process development/improvement activities.
• Process development; equipment validations and process characterization and validation experience.
• Six Sigma Black Belt or demonstrated use of Design for Six Sigma tools (DOE, problem solving, process improvement).
• Experience from medical device or other regulated industry preferred.
• Ability to guide and mentor junior on process and product development.
• Excellent communication skills.

Responsabilidades

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.
• Create documentation to support new and improved manufacturing processes.
• Use Six Sigma, Lean, and Mistake proof methodologies to develop lean and capable processes.
• Write and perform process validations (IQ, OQ, PQ/PPQ) and validate methods for inspection and controls.
• Interface with assemblers, production supervisors, leads, engineers and management daily.
• Coordinate with suppliers and external resources for new process/product plans.
• Work as part of development team to implement new devices and ensure cross-team communication.
• Assess process capabilities, innovate and implement improvements with divisional impact.
• Apply technical knowledge to design and develop processes, procedures, tooling and/or automation.
• Execute deliverables associated with PDP, Design Control, CAPA, and Quality Systems.

Conocimientos

Six Sigma Black Belt

Educación

Bachelor’s degree in Mechanical or Biomedical Engineering or related engineering

Descripción del empleo

Boston Scientific Corporation in Malaysia’s Penang region is seeking an experienced engineer to design and develop new manufacturing processes for disposable medical devices and to lead cross-functional teams in transferring products into production.

The role requires a Six Sigma Black Belt (or equivalent), 8+ years of process development experience, and a background in regulated industries. You will ensure quality systems, documentation, and continuous improvement across projects.