Embedded Software Test Engineering Lead

About Us: 

Avive Solutions, Inc. (https://avive.life) is a VC-backed healthcare technology company that has developed an FDA approved, next-generation Automated External Defibrillator (AED) and response system in an effort to – literally – save lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic team that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.

Avive is taking a fresh approach to addressing this decades-old problem by providing an advanced AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to cardiac arrest emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and novel software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.

Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! https://youtu.be/0AS_pyg4RB8

About the Role: 

This position drives Avive’s embedded software test engineering program from early design stages to commercialization and automated testing suites, ensuring that all products comply with internal, regulatory, and customer requirements. Additionally, this position plays an active role in structuring, documenting, and maintaining Avive’s software engineering practices. This is a fantastic opportunity to join a fast-paced, innovative team!

What you'll do:

• Lead the embedded software testing group, focused on testing and verifying electromechanical medical device systems via automated and manual testing practices
• Responsible for delivering test plans and overseeing the successful execution of formal software verifications
• Develop and maintain CI/CD infrastructure for automated testing
• Responsible for delivering all software project and quality documentation, including software design descriptions, design output specifications, verification plans, protocols, and reports, and software hazard analysis
• Responsible for compliance with IEC 62304, maintenance of Software SOP’s and WI’s, and adherence to overall Quality Management System
• Oversee the development and validation of software tools to aid in automated and manual testing
• Drive system end to end integration testing between internal and external systems, between different Avive hardware products, and between connected IoT hardware products and cloud-based products
• Drive the execution of software security testing and documentation, including secure coding practices, static analysis, fuzz testing, penetration testing, vulnerability assessments, and system security documentation

Who you are:

• BS degree in Computer Science or Engineering, or equivalent combination of relevant coursework and job-related experience.
• 8+ years of experience, at least 5 in the medical device industry
• Experience working on successful in-market medical device products 
• Experience working with FDA Moderate or Major Level of Concern software, and familiarity with IEC 62304 Software classifications
• Experience working with C / C++, RTOS, and/or Embedded Linux systems
• Excellent verbal and written communication skills including technical writing. Good documentation is a must!
• [Preferred] Experience with FDA Major Level of Concern Software and/or IEC 62304 Class C Software 
• [Preferred] Experience with IoT medical device products that include Cellular, Wi-Fi, Location, and/or BLE

Equal Employment Opportunity

It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.

NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

Anticipated salary range: $140,000 - $160,000