Senior Systems Engineer 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.

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 companys 4-year product pipeline and the future of clinically impactful technologies in the kidney stone space.

In This Role You Will:

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.

Who You Will Report To:

• Sr. Manager Sr. Manager Systems and Test Engineering

Requirements:

• Bachelors degree in Mechanical or Biomedical Engineering Masters or PhD preferred.
• 7 years 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 ( 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.
• Travel: Minimal less than 5%
• Work location: Pleasanton (Rosewood) on-site 4-5 days a week
• Compliance with relevant county state and Federal rules regarding vaccinations.

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 of $160000-$175000 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

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. We believe a diverse and inclusive community empowers us to act courageously care deeply and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is compliance with federal law all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer:

At Calyxo we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information such as your full name address phone number or identification documents via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of. If you receive a request for information from any other domain please contact us directly at to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.