- Sunnyvale, California, United States
- Senior
- 8+ years
Lead the development, validation, and continuous improvement of manufacturing processes for precision flexible needles, catheters, and single-use accessory assemblies.
Responsibilities
- Develop, release, and validate scalable manufacturing processes for next-generation, single-use and multi-use accessory assemblies.
- Support development of joining and forming processes such as laser welding, adhesive bonding, tipping, grinding, crimping, swaging, polymer reflow, and more.
- Define robust assembly and inspection methods for precision needle, catheter, and small-bore tubing subassemblies.
- Ensure high-quality build and test practices, including tensile, pull, puncture, and dimensional testing, as well as packaging and sterilization compatibility.
- Perform statistical analysis including Cpk, process capability analysis, DOE, ANOVA, regression analysis.
Requirements
- BS in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or related field
- Nice to have: medical device manufacturing (ISO 13485)
- Nice to have: ISO 9001
- Nice to have: regulated product development environments
- Nice to have: catheter, needle, or minimally invasive device assemblies