Systems Engineer Avation Medical Valencia, CA Job Details Full-time 14 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Laboratory testing protocol documentation Analog circuit design Electrical system design Electrical engineering Electrical performance testing Electronics test specifications Bachelor's degree in engineering Digital circuit design Production validation processes Design engineering Systems engineering SolidWorks Quality standards in production Test Execution (Quality assurance practices) Medical devices electrical engineering expertise Electrical Engineering Test validation method Python Test Planning (Quality assurance practices)

Full Job Description Position Overview:

Avation Medical is actively recruiting for a System Engineer to lead design, testing and production of the Vivally System, an FDA-cleared wearable neuromodulation treatment for overactive bladder. This role will be pivotal in designing, prototyping, testing and manufacturing of the Vivally System and advance Avation's mission to be a global leader in neuromodulation and digital health in Urology.

Key Responsibilities:

• Design and testing of printed circuit boards, electromechanical and wearable components
• Integral member of Avation Product Development team for new and sustaining products
• Manage and improve system interfaces between hardware, software and human factors
• Develop and continuously improve system designs, manufacturability and patient use
• Employ modeling, analysis and simulation to optimize system performance
• Lead and build necessary tools, setups, equipment and fixtures for hardware testing
• Coordinate Verification and Validation tests, write protocols and test execution
• Participate in IP expansion, pipeline growth and next generation architecture development
• Support manufacturing operations, cGMP, supply-chain, inventory plan and safety protocols Required qualifications:
• Bachelor's degree in electrical, mechanical, systems or industrial engineering
• 1-3 years of experience in similar roles
• Familiarity with systems engineering, architecture, and software-driven medical devices
• Knowledge of digital and analog circuit design and layout for embedded systems
• Experience with test planning, execution and protocols in a regulatory environment
• Familiarity with manufacturing processes, quality systems and document requirements
• Independent, creative, multi-tasker, collaborative with strong positive can-do attitude Desirable qualifications:
• Familiarity with systems and lab tools such as Labview, Solidworks and Python
• Knowledge of manufacturing systems such as DHR, DMR, DHF and

IQ/OQ/PQ

• Working knowledge of standards including

IEC 60601, IEC 62304, ISO 14971, ISO 13485

• Experience with HealthTech, neuromodulation, wearable or digital health systems Employment type:
• Full time employee
• Reporting to Chief Executive Officer
• On-site in Valencia, CA facility

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Retirement plan Vision insurance

Location:

Valencia, CA 91355 (Required)

Work Location:

In person