Staff 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:

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 derisk 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 Calyxos 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

• Bachelors degree in Mechanical Engineering Biomedical Engineering or related field; Masters 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 relevant medical device standards (e.g. ISO 14971 IEC 62304 IEC 60601 family).
• Track record of writing high-quality testable requirements that scale across complex systems.

Leadership & Communication

• Staff-level technical judgment and decision-making capability.
• Ability to lead through influence and technical authority rather than direct reporting lines.
• Clear concise technical communicator across disciplines and experience levels.
• Comfortable operating in ambiguity making informed trade-offs and driving alignment.

Work Conditions

• Location: Pleasanton CA (on-site presence expected 45 days per week)
• Travel: Minimal (<10%)

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 if $195000 - $205000 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.