Staff Engineer - R&D

Staff Engineer – R&D

Irvine, CA

The Staff Engineer – R&D leads technical design activities for complex medical device development programs, from early concept through final product design. This role focuses on translating user and clinical requirements into system-level designs, developing and evaluating components and assemblies, and ensuring alignment with manufacturing and regulatory expectations.

What You Will Do

• Lead design and development of components, subassemblies, and full medical device systems from concept through validation
• Translate user needs and clinical requirements into system-level engineering designs and detailed specifications
• Evaluate and select prototyping and testing methods to verify product performance and reliability
• Design and review injection-molded components for functionality, manufacturability, and cost efficiency
• Develop engineering drawings, CAD models, and design documentation aligned with design control requirements
• Drive innovation by generating invention disclosures, patents, or trade secrets based on technical developments
• Collaborate with Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to meet project milestones
• Mentor engineers and contribute to the development of engineering processes, tools, and best practices

What You Will Need

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline
• Minimum 4 years of experience working in a regulated environment
• Experience in medical device development processes
• Experience designing injection-molded components
• Experience developing mechanical assemblies using DFM principles and CAD tools (SolidWorks or equivalent)
• Knowledge of materials, manufacturing processes, and product development technologies

Preferred Qualifications

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline
• Experience in cardiovascular or vascular medical device development

• $102,700 - $171,100 USD Annual