Senior Manufacturing Engineer
StrykerAbout the role
The Senior Engineer, Manufacturing will support Manufacturing/Operations in the following areas: increase capacity, reduce scrap, improve safety, monitor existing processes, identify and implement process improvements in a regulated medical device reprocessing environment.
What You Will Do:
Support and improve existing processes using Statistical, Lean, Good Manufacturing Practice (GMP) and Six Sigma methodologies
Effectively transfer new products, design changes or line extended devices on to production floor
Foster an environment of continuous improvement and provide support to customers in all functional areas
Discuss progress and interim findings at periodic design/project review meetings
Perform Failure Analyses (FAs) and improve Functionality/Performance of medical devices
Identify and implement process improvements and machining improvements on production lines
Reduce Reject Rates(scrap)and optimize manufacturing processes
Identify and implement safety improvements on production lines
Lead the development and execution of technical protocols and, generation of reports
Develop and implement operating procedures, standard work, visual work instructions, visual work references
Provide training to Production for all new product launches and design changes to existing products or processes
Acquire knowledge of FDA/ISO requirements associated with the development of medical devices including Design Control
Perform other duties as directed or assigned by Manager
Equipment specification, procurement, validation
What you need:
Bachelor's Degree in Engineering
2 or more years of related experience required
Experience with Engineering Change Orders/Justification and Assembly Procedure Change Orders required
Demonstrated ability to plan, track and facilitate projects using applicable tools (e.g. Gantt and Pert Charts etc.) required
Ability to develop and follow systematic troubleshooting procedures to address tool and equipment issues required
Experience with Development, Analysis and Implementation of Test Lab Tests/Support required
Experience in the continuous process improvement and applying Lean Manufacturing techniques- preferred
Strong preference for experience with extrusion, polymers, micro tubing, and process validation
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