Senior Systems Engineer - Pleasanton, CA

Senior Systems Engineer - Pleasanton, CA

Pleasanton, CA

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.

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.

• Sr. Manager, Systems and Test Engineering

• 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…