Staff Systems Engineer — Medical Device Systems Architect

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

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