Process Engineer Job at Katalyst Healthcares & Life Sciences
Summary:
Process Development Engineer to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation delivery catheter systems
Project Details:
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.).
- 0 – 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
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