Systems Engineer

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