Principal SW Quality Engineer - Medical Device (Onsite)

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Comprehensive benefits

401k + ESPP

Stock options

Onsite gym

Mindfulness classes

Paid time off

Job summary

Pulse Biosciences, Inc. in Hayward, CA seeks a Principal Software Quality Engineer to lead software quality activities for the CellFX system and accessories in FDA-regulated environments.

You will develop and implement SW QA methodologies, support regulatory submissions, and collaborate with R&D, manufacturing and QA teams to ensure device safety and compliance across the product lifecycle. This role requires strong analytical skills, good communication, and the ability to drive quality

Qualifications

• 10+ years in SW quality assurance, testing, or development.
• Experience with complex energy-based medical device systems and Class III devices.
• Familiarity with FDA software validation and cybersecurity guidance.

Responsibilities

• Provide guidance on SW quality assurance, design controls, and compliance.
• Develop and maintain SW QA methodologies and processes.
• Investigate and implement best-in-class SW quality practices.
• Establish process controls for development, qualification and manufacturing.
• Develop and validate SW methods, monitor standards, perform code reviews.
• Assist with regulatory submissions and cybersecurity assessments.
• Prepare SW SOPs, test methodologies, and verification/validation reports.
• Support SW release, updates, and QA activities.
• Collaborate with Development Team to plan testing and validation.
• Perform validation and verification testing in an FDA-regulated environment.
• Support internal audits and regulatory inspections.

Skills

Software QA

Design Controls

Regulatory Compliance

Cybersecurity awareness

QNX or real-time OS knowledge

Project management

Communication skills

Testing automation

Education

Bachelor's degree in Computer Science or related field

Tools

QNX

ISO 14971

IEC 62304

MS Office

Job description

Pulse Biosciences, Inc. in Hayward, CA seeks a Principal Software Quality Engineer to lead software quality activities for the CellFX system and accessories in FDA-regulated environments.

You will develop and implement SW QA methodologies, support regulatory submissions, and collaborate with R&D, manufacturing and QA teams to ensure device safety and compliance across the product lifecycle. This role requires strong analytical skills, good communication, and the ability to drive quality