Staff Systems Engineer - Pleasanton, CA at Calyxo

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

205000.0

Posted On

18 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

System Architecture, Requirements Decomposition, Risk Mitigation, dFMEA, Medical Device Development, Verification and Validation, Technical Leadership, Jama, Fault-Tree Analysis, ISO 14971, IEC 62304, IEC 60601, Prototyping, Bench Testing, Cross-functional Leadership, Systems Thinking

Industry

Medical Equipment Manufacturing

Description

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 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 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 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. Who You Will Report To: Sr. Manager, Systems and Test Engineering 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. 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 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 4–5 days per week). Travel: Minimal (

Responsibilities

Architect and own the system-level behavior of a complex medical device ecosystem throughout the product development lifecycle. Translate user needs into technical requirements and lead the identification and mitigation of system-level risks.