Systems Engineer

$118,123 - $150,612/Yr

Inovio Pharmaceuticals - San Diego, CA

Full-time - Mid Level

Hybrid - San Diego, CA

Professional, Scientific, and Technical Services

About the position

The Systems Engineer at INOVIO will lead the design and development of medical devices, ensuring compliance with regulatory standards and collaborating with cross-functional teams. This role involves defining device concepts, managing requirements, and overseeing risk management processes to deliver innovative DNA medicines.

Responsibilities

• Work with marketing to create the User's Needs Requirements
• Create and manage System level input requirements
• Maintain the Traceability matrix
• Manage and update the Risk Management File such as System Hazard, DFMEA, SW RISK and URRA analysis
• Manage the device user manual
• V&V planning and manage execution
• Update and maintain the Device Master Record (DMR)
• Ensure compliance to FDA and MDDR regulations
• Maintain the device standards list
• Manage external contractors such as Software vendors
• Review software documentation
• Collaborate with cross-functional teams to establish agreement on design implementations
• Work with legal and quality to bring new external vendors on-board
• Complete other engineering duties as assigned.

Requirements

• B.S. degree in Engineering related field
• Minimum 5 years of medical device experience
• Thorough understanding of ISO13485 quality control and documentation or equivalent standards from other regulated industries
• Understanding of Risk Management based on IEC 14971
• Understanding of IEC 62304 Software life cycle process
• Understanding of Safety standards such as IEC 60601-1 and ISO 11608 for Needle-based injection systems
• Solid understanding of design control based on 21CFR820.11

Benefits

• 401(K) retirement plan with Corporate Matching
• Annual Incentives
• Medical, Dental, and Vision
• Generous Paid-time off program and company holidays
• Hybrid work environment
• Physical, Mental, & Financial Wellness Program
• Company-paid Life Insurance plans
• Long & Short-Term Disability
• Flexible Spending accounts for medical and dependent care expenses
• Employee Discount Perks