Principal SW Quality Engineer for Bioelectric Devices

pulsebiosciences; Hayward (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Supplemental insurance

Job summary

Pulse Biosciences seeks a Principal Software Quality Engineer to oversee software quality assurance for the CellFX system and accessories. You will guide verification/validation, design controls, and regulatory filings across R&D, manufacturing, and clinical investigations.

The role requires a strong background in SW QA for medical devices, collaboration with development teams, and support for cybersecurity and labeling activities in an FDA-regulated environment.

Qualifications

• Bachelor's degree is required.
• Experience in software quality assurance within medical devices is preferred.
• Familiarity with design controls and regulatory expectations is expected.

Responsibilities

• Provide expertise in SW QA, design controls, and compliance for product development and manufacturing.
• Develop and maintain SW QA methodologies and processes.
• Support regulatory submissions and cybersecurity assessments.
• Lead software verification, validation, and release activities.
• Coordinate with cross-functional teams to ensure product quality across the lifecycle.

Skills

SW quality assurance

Design controls

Regulatory compliance

Software verification & validation

Cybersecurity awareness

Education

Bachelor's degree in

Job description

Pulse Biosciences seeks a Principal Software Quality Engineer to oversee software quality assurance for the CellFX system and accessories. You will guide verification/validation, design controls, and regulatory filings across R&D, manufacturing, and clinical investigations.

The role requires a strong background in SW QA for medical devices, collaboration with development teams, and support for cybersecurity and labeling activities in an FDA-regulated environment.