Staff Systems Engineer - Pleasanton, CA

Calyxo; Pleasanton (CA); On-site; USD 195,000 - 205,000; Full time

Benefits offered by this job

Stock options

401(k) and healthcare benefits

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA, is seeking a Staff Systems Engineer to architect, validate, and own the system-level behavior of a complex medical device ecosystem across the product lifecycle.

You will define the end-to-end system architecture and translate user needs into testable requirements. Ideal candidates have hands-on medical device experience, strong systems thinking, and the leadership to coordinate hardware, software, disposables, and clinical use environments while ensuring robust

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering; Master’s or PhD preferred.
• 12+ years in medical device development with system architecture ownership.
• Hands-on experience with single-use disposables and capital equipment with pumps, sensors, and closed-loop control.
• Experience architecting systems integrating hardware, disposables, and software.

Responsibilities

• Architect system architecture with emphasis on risk mitigation and patient safety.
• Own creation, maintenance, and verification of system-level requirements and verification strategies.
• Lead DFMEAs and ensure traceability between requirements, risks, and verification.
• Coordinate with mechanical, electrical, firmware, software, clinical, quality, and product teams.
• Mentor engineers on systems thinking and architectural rigor.

Skills

Systems thinking

Technical leadership

Systems engineering

Hardware-software integration

Requirements traceability

Risk analysis

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s or PhD strongly preferred

Tools

Jama

DFMEA

Job description

Summary:

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.

Calyxois seeking a StaffSystems Engineer toarchitect,validate,andown the system-level behavior of a complex medical device ecosystem throughout the entire product development lifecycle.

You will define and own the end-to-end system architecture, translate user and business needs into robust system and subsystem requirements, validate architectural decisions through prototyping and bench testing, and proactively de‑risk critical technical challenges. This role carries direct accountability for system-level requirements ownership and verification.

The ideal candidate combines hands‑on medical device experience, 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:

• Architect systems with a strong focus on technical and patient risk mitigation.
• 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 performance, safety, and reliability.
• Decompose user, clinical, and business needs into clear, testable system and subsystem requirements.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 risks.
• 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 system’s 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 Calyxo’s 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

Education & Experience:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; Master’s or PhD strongly preferred.
• 12+ years of experience in medical device development, with significant ownership of system architecture.
• Strong hands‑on experience with both:
• Single‑use disposable systems.
• Capital equipment incorporating pumps, sensors, and closed‑loop control.

Technical Expertise:

• 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 requirement 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 4–5 days per week).
• Travel: Minimal (<10%).

WhatWeOffer:

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 range of $195,000 - $205,000 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.

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. 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 required. In 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.