Boston Scientific Senior/ Principal Process Development Engineer 

Malaysia, Penang 

114003043

Job Responsibilities:

• 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.