Senior Process Development Engineer

Boston Scientific; Seberang Perai; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific Malaysia is seeking a seasoned Process Development Engineer to design and develop manufacturing processes for disposable medical devices, leading cross-functional efforts to transfer products into production. You will drive DOE to optimise equipment parameters and apply Six Sigma and Lean principles across projects embedded in a regulated environment.

Key activities include creating documentation, performing IQ/OQ/PQ validations, and ensuring quality systems compliance.

Qualifications

• Bachelor's or higher in mechanical/biomedical or related engineering field.
• At least 8 years of demonstrated process development/improvement experience.
• Experience with medical devices or regulated industries preferred.

Responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimise 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.)

Skills

DOE

Problem solving

Process improvement

Six Sigma Black Belt

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Related engineering degree

Tools

Design of Experiments

IQ/OQ/PQ knowledge

Job description

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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 Responsibilities:

Develop and implement new manufacturing processes for new disposable medical devices.

Perform Design of Experiments for process definition and to optimise 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 requireprocess at least Bachelor’s degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.

Candidate require has at least 8years 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.