Senior Systems Engineer - Pleasanton, CA

Senior Systems Engineer - Pleasanton, CA

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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.

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 role that directly impacts the company’s 4-year product pipeline and the future of clinically impactful technologies in the kidney stone space.

• 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
• 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
• 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
• 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

• Bachelor's degree in Mechanical or Biomedical Engineering;
  Master’s or PhD preferred
• 7+ years of 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
• Must be self‑directed, self‑motivated and able to multi‑task in a fast‑paced environment with multiple priorities
• Knowledge and ability to…