Senior Process Development Engineer

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

Purpose Statement

This position is responsible for the design and development of new and improved manufacturing processes and ensuring efficient and effective transfer of product into production. Core team member and site lead on a cross functional team of disposable medical devices. Looks to improve existing processes within the New Product Development project, which then may be shared across other lines. Manages and leads complex projects independently with minimal supervision.

Purpose Statement

This position is responsible for the design and development of new and improved manufacturing processes and ensuring efficient and effective transfer of product into production. Core team member and site lead on a cross functional team of disposable medical devices. Looks to improve existing processes within the New Product Development project, which then may be shared across other lines. Manages and leads complex projects independently with minimal supervision.

Job Resposibilities

• 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 of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’.
• Write and perform process validations (IQ, OQ, PQ/PPQ) and validate methods for inspection for verification and process controls.
• Interface directly with assemblers, production supervisors, leads, engineers and management daily.
• Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans.
• Work as part of a development team in developing and implementing new devices. Facilitate excellent communications between all team members.
• Assesses process capabilities, innovates and implements process improvements on key projects with divisional impact.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Executes the functional deliverables associated with the PDP, Design Control, CAPA, and all Quality Systems.
• As needed; plans, organizes, and participate all aspects of technical reviews.
• Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOM’s, Routers, FMEA’s, etc.)

Job Requirements

• Candidates require process at least Bachelor’s degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.
• Candidate require has at least 8 years of demonstrated process development / improvement activities.
• Process Development; equipment validations and process characterization and validation experience.
• Prefer candidate from medical device or other regulated industry experience.
• Required: Six Sigma Black Belt or demonstrated use of Design for Six Sigma tools (DOE, problem solving, process improvement).
• Demonstrated ability to develop processes from concept to production.
• Guide and mentor junior on process and product development.
• Excellent communication skills.

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.