Staff Systems Architect — Medical Devices

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

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.