Senior R&D Engineer; Onsite Irvine, CA

The Senior R&D Engineer supports project teams in the development of medical devices. This includes writing or verifying specifications, developing testing and product processes, and designing fixtures to ensure the concepts and/or prototypes meet requirements.

• Under minimal supervision; research, design, develop, modify, and verify components/modules for medical device product development and/or miscellaneous activities.
• Translate and/or define design inputs to engineering specifications and produce sub-system level designs.
• Apply fundamental and some advanced concepts, practices and procedures to problem solving.
• Demonstrate advanced understanding of customer needs and design inputs.
• Demonstrate proficiency with product’s intended use and clinical procedures.
• Learn how the financial models are constructed.
• Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements.
• Independently create or refine engineering documentation, such as the Design History File.
• Follow R&D procedures like design controls and risk management, per the Quality Management System.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

• Bachelor of Science Degree in Engineering;
  Mechanical Engineering or Biomedical plus 2+ years of relevant work experience.

• Master of Science Degree in Engineering, Mechanical Engineering or Biomedical preferred.
• Working knowledge and understanding of mechanical engineering practices and design principles within a regulated environment.
• Technical ability to create engineering drawings and models, applying GD&T and CAE tools.
• Demonstrated ability to apply knowledge of materials and manufacturing processes to product design.
• Knowledge of Machine Shop and 3D printing practices.
• Knowledge of Medical Device Manufacturing.

$89,400 - $148,900 USD Annual