Senior Systems Engineer - Pleasanton, CA

Calyxo, Inc. • Pleasanton, CA

4d • $160,000 - $175,000 • Onsite

About The Position

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. Summary: We are seeking a highly capable Senior Systems Engineer to drive system-level requirements, architecture, and interface definition across a complex multi-product medical device ecosystem. This role is central to shaping next-generation endoscopic platforms, capital equipment, embedded software, and multiple disposables. You will own the creation, decomposition, and validation of requirements across hardware, software, and disposables. You will play a critical role in defining system architecture, managing interfaces between subsystems, guiding design teams, and ensuring external development partners deliver against clear, testable, and appropriately flexible requirements. This is a deeply cross-functional that directly impacts the company’s 4-year product pipeline and the future of clinically impactful technologies in the kidney stone space.

Requirements

• Bachelors degree in Mechanical or Biomedical Engineering, Masters or PhD preferred.
• 7+ year's experience.
• Strong expertise in fluidics (irrigation, vacuum, pressure/flow systems).
• Experience with vision/imaging systems and their system-level behavior.
• Proven experience owning system architecture and interface control documents (ICDs).
• Hands-on experience with disposables and capital equipment integration.
• Proficiency with Jama, FMEAs, and fault-tree analysis.
• Deep knowledge of major U.S. medical device standards (14971, 62304, 60601-x, etc.).
• Skilled in writing clear, testable, non-prescriptive requirements across hardware and software.
• Strong communicator, fast-moving, decisive, and comfortable driving alignment among diverse teams.
• 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.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Responsibilities

• Requirements Development & Ownership Own the development of system-level and subsystem-level requirements , including: performance requirements (fluidics, vision, disposables, embedded systems), interface requirements, regulatory compliance requirements,
• Lead decomposition of user needs into clear, measurable system and subsystem requirements
• Ensure traceability is complete across the full lifecycle of the system
• System Architecture & Interface Leadership Serve as a key contributor to the multi-product system architecture across capital equipment, endoscopes, disposables, and embedded software.
• Own interface definition and control , including mechanical, electrical, software API, fluidic, and system-level behavioral interactions.
• Challenge design decisions and drive bench-top and animal trade studies to ensure architectural alignment with requirements.
• Cross-Functional & External Collaboration Partner closely with mechanical, electrical, firmware, software, clinical, quality, and product teams to ensure alignment and understanding of system needs.
• Lead and facilitate formal requirements reviews , design discussions, and architecture workshops.
• Work directly with external contract design firms by: providing clear system/subsystem requirements, reviewing design concepts, ensuring interface consistency, aligning deliverables with internal architecture and verification needs.
• Risk & Systems Engineering Processes Develop and maintain dFMEAs for system-level features and interactions.
• Ensure requirements link to risks, mitigations, and verification Support test teams by ensuring all requirements are objectively verifiable and aligned with test method needs.

Benefits

• A competitive base salary of $160,000-$175,000 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees