Staff Engineer, R&D

Location

Aliso Viejo, California, USA

Department Name

643-R&D Admin-Coil/Stroke

Qualifications

1. Bachelor’s degree in Engineering or Scientific field. 
2. Minimum six (6) years of relevant work experience in medical device industry. 
3. Strong written and verbal communication skills. 
4. Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics. 
5. Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs. 
6. Strong design expertise developing and validating embedded software/firmware for medical devices following applicable requirements (e.g., ISO 62304). 
7. Strong design experience in designing and developing electro-mechanical medical device and associated test requirements (e.g., IEC 60601 standards series). 
8. Proficient computer skills, including MS Word, Excel, Outlook, and Teams. 

1. Advanced degree in Engineering or Scientific field. 
2. Experience designing components optimized for injection molding. 
3. Experience with developing user centric industrial designs for medical devices. 
4. Experience with Finite Element Modeling. 
5. Experience designing complex mechanical/electromechanical systems. 
6. Experience designing enclosures, chassis, and spatial packaging of components. 
7. Experience designing active implantable devices and knowledge of associated requirements (e.g., ISO 14708). 
8. Experience developing and testing mobile applications for medical devices. 
9. Working knowledge of medical devices and FDA regulations. 
10. Experience with CAPA systems, including complaint handling. 
11. Ability to receive the appropriate inoculations required to enter an operating room environment. 

External-Facing Title

Staff Engineer, R&D

Posting Country

US - United States

Salary Range

$111,000 - $145,500 (Compensation can vary based on education, experience and skill sets)