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.  

What You Will Do

• Under minimal supervision; research, design, develop, modify, and verify components/modules for medical device product development and/or misc. 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.  

What You Need (Required Qualifications)

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

Preferred Qualifications (Strongly Desired)

• 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.