Staff Systems Engineer - Pleasanton, CA

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

Benefits offered by this job

Competitive base salary

Stock options

401(k)

Healthcare insurance

Paid vacation

Job summary

Calyxo, Inc. is seeking a Staff Systems Engineer in Pleasanton, California, to lead system architecture and manage system-level requirements for innovative kidney stone treatment devices.

The ideal candidate will have over 12 years of experience with medical device development, focusing on risk mitigation and technical leadership. A competitive salary of $195,000–$205,000, along with benefits, is offered for the right candidate.

Qualifications

• 12+ years of experience in medical device development.
• Strong knowledge of medical device standards (e.g., ISO 14971, IEC 62304).
• Experience creating and maintaining system-level requirements.

Responsibilities

• Architect systems focused on technical and patient risk mitigation.
• Own creation and verification of system-level requirements.
• Lead identification and mitigation of system-level risks.

Skills

System architecture

Risk mitigation

Technical leadership

Medical device standards

Requirements gathering

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field

Master’s or PhD

Tools

Jama

dFMEAs

Fault-tree analysis

Job description

Summary

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, focused on kidney stone treatment. We are looking for a Staff Systems Engineer to architect, validate, and own the system-level behavior of a complex medical device ecosystem throughout the entire product development lifecycle.

Responsibilities

System Architecture

• Architect systems with a focus on technical and patient risk mitigation.
• Establish and control system interfaces across 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, emphasizing 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.
• Define and support verification strategies, ensuring requirements are objectively testable and clinically relevant.
• Actively de‑risk novel or critical aspects through early experimentation and focused learning cycles.

Cross‑Functional Technical Leadership

• Serve as the 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 to ensure a fully functional system.
• Provide clear technical direction and interface control to external development partners.
• Mentor engineers on systems thinking, requirement quality, and architectural rigor.

Reporting

Systems and Test Senior Manager

Requirements

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.
• Hands‑on experience with both single‑use disposable systems and 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 requirements traceability.
• Strong working knowledge of 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.
• 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%).

What We Offer

• Competitive base salary range of $195,000–$205,000 and variable incentive plan.
• Stock options – ownership and a stake in a growing mission‑driven company.
• Employee benefits package including 401(k), healthcare insurance, and paid vacation.

Equal Opportunity Employment

Calyxo is proudly an equal opportunity employer and welcomes applicants without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics.

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