Staff Systems Engineer, Medical Devices - AQMed

About the Role

As hardware test engineer on our AQMed team, you will help develop benchtop and portable sensing systems, configure their software for data capture, create test plans aligned to product requirements, analyze sensor data to provide performance feedback to product design engineers, and take ownership of system verification and validation (V&V). In this role, you will work cross-functionally with our hardware, software platform, and clinical teams to ensure our CardiAQ™ device performs with actionable diagnostic insights in our users’ emergency department workflow. A successful hardware test engineer will serve as the bridge connecting our medical devices in development to clear test data and analysis that proves their safety and performance towards FDA market clearance. This individual ensures our products meet the established performance requirements for use in human clinical trials. High product quality is essential to transforming the standard of cardiac emergency care.

What You’ll Do

• Develop verification and validation test bench systems and automated frameworks for acceptance testing of devices, within the regulated quality management system for our FDA submission.
• Assemble and configure cardiac sensor hardware to stream useful data in various prototyping stages during development.
• Analyze signal processing pipeline outputs to identify hardware + platform issues and recommend iterations to the developing product. 
• Work with sensor physics, mechanical engineering, quality assurance, and clinical teams to develop calibration and validation experiments that derisk device concepts along the development path.
• Develop dependable manufacturing hardware test fixtures and customized V&V test routines in Python, which assess performance of sensors and systems throughout assembly - from bare metal to deployment-ready to in-field-service.
• Determine the root cause of failure modes for hardware components and systems and develop actionable plans for continual quality improvement.
• Become an expert operator of our cardiac devices, understanding deeply their performance margins and how to challenge those margins reliably in test scenarios.

About You

• BS degree in biomedical, systems, or mechanical engineering, or similar field 
• 6+ years in medtech product engineering, preferably on a team developing Class II or III regulated devices through market clearance studies.
• You are proficient in configuring hardware sensor systems, and - in a collaborative programming partnership with SWE colleagues - developing automated Python routines for version-controlled test data generation and analysis.
• You are experienced in developing quality verification and validation test systems and processes for medtech products: specifically: mechanical, electrical and sensor test development at subsystem and system level.
• You have technical familiarity with the key medtech product development disciplines: mechanical, electrical, human factors/usability / industrial design, quality, and systems engineering. 
• You drive technical decisions with the North Star of solving unmet clinical needs while connecting and communicating the insights and contributions of skilled colleagues on your team.  
• Action-oriented: you proactively create solutions, knowing that a delay in our product launch means a delay in impacting patient care.
• You are willing and able to work from our Palo Alto location 80% of the time (hybrid), with occasional travel to support our devices in the field after they are deployed to hospitals. 

Nice to Haves 

• You’ve worked on complex capital equipment, sensing, or robotic devices.
• You’ve led the development of V&V test processes through FDA clearance.
• You’ve supported medtech product market clearance/approval applications.
• You’ve assembled and tested hardware components within a regulated industry manufacturing environment.  
• You’ve successfully collaborated with outsourced engineering resources and contract manufacturing partners.
• You have experience in the design transfer to manufacturing phase of medtech product development.
• You’ve fabricated rapid-prototype hardware and are familiar with/expert at the associated toolsets: 3D printing, milling, machining, etc.  
• Cardiovascular device/cardiology experience, familiarity/expertise in the electrophysiology of the heart.

The US base salary range for this full-time position is expected to be $142k-$239k per year. Our salary ranges are determined by role and level. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.