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R&D Engineer

Job Description

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.
Job Requirements:
  • 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.