Principal Software Quality Engineer — Equity & Growth

Pulse Staffing Limited

Hayward (CA)

On-site

USD 165,000 - 200,000

Full time

5 days ago

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Job summary

Pulse Biosciences is seeking a Principal Software Quality Engineer to lead quality assurance for the CellFX software ecosystem. You will shape QA strategies, ensure regulatory compliance, and drive robust verification and validation across development, manufacturing, and clinical efforts.

The role requires deep experience in software quality for Class III medical devices, strong design controls, risk management, and cybersecurity practices, with hands-on leadership in a fast-paced, regulatory

Qualifications

10+ years hands-on SW QA, SW testing, or SW development experience.
5+ years with complex energy-based medical device systems (Class III) with SW.
Experience with Design Control, Risk Management, and CAPA.
Familiarity with IEC 62304, ISO 14971, and cybersecurity guidance.
Excellent written and verbal communication and project management skills.

Responsibilities

Provide guidance to product development and manufacturing on SW quality assurance.
Develop and maintain SW quality engineering methodologies and systems.
Investigate and implement best-in-class SW QA practices.
Support regulatory submissions and cybersecurity assessments.
Develop SW SOPs, test methodologies, and verification/validation reports.
Collaborate with Software Development to plan tests.