Staff Engineer - R&D

Staff Engineer – R&D

Irvine, CA

• 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

• 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 (Solid Works or equivalent)
• Knowledge of materials, manufacturing processes, and product development technologies

• 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

Health benefits include:
Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

Financial benefits include:
Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.