Summary:
Process Development Engineer to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation delivery catheter systems
Project Details:
Evaluation of production equipment
Production support and process validation
Interface with vendors for incoming components
Troubleshoot manufacturing process and equipment
Protocol and report writing
Execution of IQ/OQ/PQs, Test Method Validation and PPQs
Generate and modify manufacturing process documentation
Work with cross functional teams as required
Develop and implement process improvements
Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence
Establish processes based on product and print specifications
Evaluate process and design alternatives based on design for manufacturability principles
Understands principles of Cost of Goods Sold
Manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.).
Job Experience:
* 4 years engineering experience
Experience designing and testing medical devices preferred
Experience developing manufacturing processes and technologies and designing for manufacturability preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Experience with molding, catheter shaft construction/bonding, or coating processes preferred
Hourly Rate: 48-63
Job Type: Full-Time, Permanent