Staff Systems Integration and Test Engineer - Pleasanton, CA

Summary:  

Calyxo is seeking a highly skilled and innovative Staff Systems Integration and Test Engineer. In this role, you will independently design and build advanced R&D test fixtures, architect and execute verification strategies, and drive system-level integration testing for a next-generation kidney-stone treatments. 

This is a deeply hands-on, cross-functional role that blends mechanical, electrical, firmware, clinical, and system-level engineering. You will work directly with design teams, clinical engineering, and system architects to define, measure, and validate performance in both benchtop test fixtures and simulated clinical use environments. 

Your work will directly shape system requirements, test methods, and performance metrics — and ultimately impact clinical outcomes in the kidney stone space. 

In This Role, You Will: 

Test Fixture Design & Development 

• Independently design, build, and validate fluidic, mechanical, and optical R&D test fixtures. 
• Own the full lifecycle of fixtures: creative concept, CAD (SolidWorks), fabrication coordination, hardware integration, data acquisition, and refinement. 
• Integrate sensors for pressure, flowrate, vacuum, optical metrics, and other key performance parameters. 
• Develop light Python scripts for data processing, device interaction, and basic automation. 

Systems Integration & Verification 

• Own system-level integration testing for the endoscopic platform. 
• Lead development of performance-focused test methods, especially around fluidics and clinical-relevant behaviors. 
• Create and execute verification plans at the system and subsystem level in coordination with design and development teams. 
• Work within a phase-gated (waterfall) program while helping drive agile testing practices inside R&D. 

Requirements & Traceability 

• Collaborate with systems architects to define, refine, and quantify system requirements. 
• Ensure requirements are measurable, testable, and clinically relevant. 
• Support development and evolution of traceability matrices, verification protocols, and engineering documentation. 

Clinical & Biologic Model Testing 

• Partner with clinical engineering to develop methods for capturing essential data from benchtop biologic and ex vivo models. 
• Support occasional large-animal lab activities as needed to evaluate integrated system performance. 

Cross-Functional Collaboration 

• Mentor junior engineers on creative and quality test solution generation 
• Work closely with teams across mechanical, electrical, firmware, systems, quality, and clinical engineering. 
• Serve as a key technical voice representing test and integration considerations in design reviews and architecture decisions. 

Who You Will Report To: 

•   See Organizational Chart 

Requirements: 

• Bachelors degree in Mechanical or Biomedical Engineering, Masters or PhD preferred. 
• 8+ year's experience. 
• Ability mentor junior engineers on the following 
• Demonstrated expertise in fluidics or vacuum-based systems. 
• Strong hands-on experience with: 
• Data acquisition systems 
• Fluidic and vacuum test equipment 
• Instrons or mechanical pull/force systems 
• Sensors for pressure, flowrate, and mechanical metrics 
• Strong SolidWorks proficiency (designing fixtures, assemblies, and test hardware). 
• Python scripting for data processing and basic device/fixture control (or other language to read sensor output and control basic motor components) 
• Familiarity with medical device standards and quality systems (e.g., 60601-1, 62366-1, 62304), especially as they relate to performance testing and verification. 
• Ability to independently drive fixture design, test method development, and system integration activities with minimal oversight. 
• Excellent communication and cross-functional collaboration skills. 
• Strong problem-solving skills and experience working as part of multifunctional technical project teams through all development lifecycle phases. 
• Experience in requirements definition, design verification, change management and risk control. 
• Excellent technical writing and verbal communication skills.  
• Ability to work independently or in a team setting required.  
• Must be self-directed, self-motivated and be able to multi-task in a fast-paced environment with multiple priorities. 
• Knowledge and ability to interpret and follow applicable regulations, guidelines, and policy statements is required. Must have experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.  
• Travel: Minimal, less than 5% 
• Work location: Pleasanton (Rosewood), on-site 4-5 days a week 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer an attractive compensation package, which includes: 

• A competitive base salary range of $175,000 - $195,000 and variable incentive plan  
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation