Position Title:Sr. Process Development Engineer
Company Background:Medical Manufacturing Company
Location:Penang
Tenure:Permanent
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.
Assess process capabilities, innovate, and implement process improvements on key projects with divisional impact.
Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.
Execute the functional deliverables associated with the PDP, Design Control, CAPA, and all Quality Systems.
Plan, organize, and participate in all aspects of technical reviews as needed.
Collaborate to ensure proper documentation is completed to meet quality systems requirements (e.g., GOIs, BOMs, Routers, FMEAs, etc.).
Job Requirements:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering degree.
At least 8 years of demonstrated process development/improvement activities.
Experience in process development, equipment validations, and process characterization and validation.
Preferred experience in medical device or other regulated industries.
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.
Ability to guide and mentor juniors on process and product development.
Excellent communication skills.
Minimum Experience:8 Years
Work Location:Penang#J-18808-Ljbffr