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.

Job Description