Systems Engineer

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.

• 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.

• 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.

• 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.

• 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.

Systems and Test Senior Manager

• 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.

• 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.

• 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.

• Location:
  
  Pleasanton, CA (on‑site presence expected 4-5 days per week).
• Travel:
  Minimal (