5 - 7 years experience • Medical Devices & Diagnostics
Role: Manufacturing Engineer
Location: Franklin Lakes, NJ
Customer: Becton Dickinson & Company
Keywords: Disposable medical device design & development, manufacturing, Medical product sustenance, Medical device Disposables
· Product Design / product sustenance experience
· Manufacturing process knowledge
· Knowledge on standards and regulatory requirements for various regions
· Fixture development & selection
· Technical (report) writing
· Basic Mechanical Engineering
· Disposable device development
· Change control Management
· Design verification
· Plastic component design & Injection molding process
· Tolerance analysis
· Sheet metal component design
· ISO13485 / FDA Guidelines
· Solid works
Desired Skills: Leadership, Project Management, Coordination, Learnability
· Work with vendors and automate manufacturing equipment and transition into support the process as production ramps-up.
· Working at the direction of the engineering leader, to oversee internal and external resources, in the development of manual / semi-automated / full-automated processes for product assembly.
· Position supports development of manufacturing methods and fixtures, automation process development with third-party vendors, and coordination of the test method development as an R&D liaison with process transition.
· Applylean manufacturing methodologies to characterize, debug, and optimize manufacturing processes.
· Performing process development, conducting FAT, SAT and process validations.
· Support root cause investigations and manufacturing process improvements.
· Design and characterization of prototype equipment & pilot processes.
· Identify methods & fixtures, create specifications & acceptance protocols for process equipment.
· Develops and maintains good rapport with business leaders, otherinternal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
· Assisting stakeholders in identifying and verifying automation methods for batch processing of artwork and/or CO preparation.
Bachelor’s / Master’s degree in Mechanical