Staff Systems Engineer - Pleasanton, CA

Calyxo • Pleasanton, CA

1d • Onsite

About The Position

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 throughout 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 de-risk 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.

Requirements

• 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.
• 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
• 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.
• 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.
• Legal authorization to work in the United States is required.

Responsibilities

• 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.
• 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.
• 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.
• 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 Calyxo’s system architecture and verification strategy.
• Mentor engineers on systems thinking, requirement quality, and architectural rigor.

Benefits

• A competitive base salary if $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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior