Principal SW QA Engineer – Med Devices (FDA/Cyber)

Pulse Biosciences, Inc.; Hayward (CA); Sur place; USD 165 000 - 200 000; Plein temps

Avantages offerts par ce poste

Stock options

Employee Stock Purchase Plan

401k retirement savings plan

Onsite gym

Résumé du poste

Pulse Biosciences, Inc. in Hayward, CA is seeking a Principal Software Quality Engineer to lead quality assurance for the CellFX system software and related regulatory deliverables.

This role demands deep expertise in design controls, validation, and cybersecurity within an FDA-regulated environment. You will drive SW QA methodologies, collaborate with development and manufacturing teams, support regulatory submissions, and help shape quality systems and post-market activities at a fast-growing

Qualifications

• Experience in software QA for medical device or FDA-regulated environments.
• Familiarity with IEC 62304 and ISO 14971 risk management.
• Strong writing skills for test protocols and regulatory documentation.

Responsabilités

• Lead SW QA activities for CellFX software and accessories; ensure verification and validation.
• Develop and maintain SW quality engineering methodologies and practices.
• Support regulatory submissions and cybersecurity assessments.

Connaissances

SW quality assurance

Software testing

Regulatory compliance

Design controls

Cybersecurity

Documentation

Formation

Bachelor's degree in Computer Science/Software Engineering or related field

Outils

Microsoft Office

Description du poste

Pulse Biosciences, Inc. in Hayward, CA is seeking a Principal Software Quality Engineer to lead quality assurance for the CellFX system software and related regulatory deliverables.

This role demands deep expertise in design controls, validation, and cybersecurity within an FDA-regulated environment. You will drive SW QA methodologies, collaborate with development and manufacturing teams, support regulatory submissions, and help shape quality systems and post-market activities at a fast-growing