Staff Systems Engineer - Pleasanton, CA

About the role

Calyxo is seeking a Staff Systems Engineer with expertise in fluidic systems to architect, validate, and own the system-level behavior of a complex medical device ecosystem thoughought the entire product development lifecycle. You will define and own the end-to-end fluidic system architecture, translate user and business needs into robust system and subsystem requirements, validate architectural decisions through prototyping and bench testing, and proactively de‑risk critical technical challenges. This role carries direct accountability for system-level requirements ownership and verification. The ideal candidate combines hands-on fluidics expertise, strong systems thinking, and the technical leadership expected of a staff-level engineer operating across hardware, software, disposables, and clinical use environments. In This Role, You Will: System Architecture & Fluidics Leadership Serve as the architect and technical owner of the system with strong focus on the fluidic performance Define the end-to-end system architecture encompassing capital equipment, endoscopes, disposable tubing sets, sensors, pumps (positive and negative), and control software. Establish and control system interfaces, including fluidic, mechanical, electrical, and software-control boundaries Drive architectural trade studies using bench testing, prototyping, and simulation to validate design decisions. Ensure architectural robustness across intended use, misuse, fault conditions, and edge cases. Requirements Ownership & Decomposition Own creation, maintenance, and verification of system-level requirements, with particular emphasis on fluidic performance, safety, and reliability. Decompose user, clinical, and business needs into clear, testable system and subsystem requirements across: Disposable fluid paths Pumping and flow-control subsystems Sensors and feedback loops Ensure complete traceability from user needs through requirements, risks, mitigation, and verification. Write requirements that are technically precise, non-prescriptive, and verification-ready. Risk Reduction & Technical Validation Lead identification and mitigation of system-level fluidic risks, including pressure excursions, occlusions, leaks, compliance variability, air management, and failure modes across reusable and disposable components. Own or significantly contribute to system-level dFMEAs, ensuring strong linkage between requirements, risk controls, and verification activities. Define and support system-level verification strategies, ensuring requirements are objectively testable and clinically relevant. Actively de-risk novel or critical aspects of the system through early experimentation and focused learning cycles. Cross-Functional Technical Leadership Serve as the fluidics and systems subject-matter expert across mechanical, electrical, firmware, software, clinical, quality, and product teams. Lead architecture reviews, requirements reviews, and system-level design discussions. Work closely with other technical leads (mechanical, electrical, and SW) to ensure a fully functional system Provide clear technical direction and interface control to external development partners, ensuring alignment with Calyxo's system architecture and verification strategy. Mentor engineers on systems thinking, requirement quality, and architectural rigor. Who You Will Report To: Sr. Manager, Systems and Test Engineering

Requirements

• Education & Experience
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field; Master's or PhD strongly preferred.
• 12+ years of experience in medical device development, with significant ownership of system architecture.
• Demonstrated expertise in fluidics, including irrigation, aspiration, pressure and flow control, and vacuum systems.
• Strong hands-on experience with both:
• Single-use disposable systems
• Capital equipment incorporating pumps, sensors, and closed-loop control
• Technical Expertise
• Deep understanding of positive and negative pumping technologies and their control strategies.
• Experience architecting systems that integrate hardware, disposables, and software
• Proven ownership of system-level requirements and verification.
• Proficiency with Jama (or equivalent), dFMEAs, fault-tree analysis, and requirements traceability.
• Strong working knowledge of

Benefits

Additional Information

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

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