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Alchemy are currently partnering with a global technology firm who are looking to recruit a R&D Engineer to be based onsite in Irvine, CA.
- Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience
- The R&D Engineer with experience in catheters or equivalent higher-class devices.
- Prepare product design verification testing (DVT) protocols and report against design requirement and risk assessment using external standards.
- Prepare single use sterile package design verification testing (DVT) protocols and report against design requirement and risk assessment using external standards (Aging, Shipping, sterilization etc..,).
- Expertise in ISO 11607-1 & -2 Packaging for terminally sterilized medical devices
- Medical Device Labeling updated
- Prepare technical product documentation including design history files, drawings, bills of materials, Design Verification protocols and reports, engineering change orders (ECO), etc.
- Self-sustained capability to solve design-related challenges and timely support to cross-functional teams as a subject matter expert.
- Design and develop test methods to support additional studies post-commercialization. Plan and execute on product development deliverables.
- Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device and systemic failures.
- Hands on Solidworks Experience 2D / 2D.
- R&D related Labeling Experience.
- EU-MDR – documentation and process experience.