Principal Software Quality Engineer

The role

The Principal Software Quality Engineer will perform quality assurance activities for software and system development, verification, and validation. This role supports the CellFX system and accessories in support of research, manufacturing, regulatory, and clinical efforts.

What you will do

• Provide expertise and guidance to product development and manufacturing teams in SW quality assurance, design controls and compliance.
• Develop, establish and maintain SW quality engineering methodologies, systems and practices.
• Identify and implement effective process control systems.
• Develop and validate SW methods, monitor medical device SW standards, and perform SW code review.
• Assist with preparation of regulatory submissions and assessments related to software changes and cybersecurity.
• Develop SW standard operating procedures, test methodologies, and verification & validation protocols and reports.
• Design and implement methods for SW release, field upgrade, and final quality assurance.
• Work with the Software Development Team to plan and improve development test processes.
• Perform validation and verification testing of medical devices in an FDA regulated environment.
• Support internal quality audits, management review, and FDA/Notified Body audits.

Required qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering or related field.
• 10+ years hands-on working experience in the field of SW quality assurance, SW testing, and/or SW development.
• 5+ years working with complex energy-based medical device system and Class III devices with SW.
• Familiarity with the use of quality disciplines, tools, and methodologies.
• Working experience with various FDA software validation and Cybersecurity guidance’s and IEC 62304 Software Lifecycle process standard requirements.
• Working knowledge and experience in Design Control, Design & Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA progra
• ANSI/AAMI/IEC 62304:2006 Medical device software –Software life cycle processes.
• Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and Risk Assessment (ISO 14971: 2019) including Cybersecurity practices and implementation.
• Experience writing technical documentation, test protocol, test reports, etc.
• Excellent oral and written communication and project management skills.
• Hands-on experience preparing, managing and submitting major regulatory submissions.
• Proficient knowledge and skill in Microsoft Office Suite applications.

Nice to have

• Cardiovascular devices are preferred.
• Background in software test development, test methodologies and test automation for native applications built QNX or Similar OS.

Benefits

• A variety of health insurance plans and supplemental insurance options
• 401k retirement savings plan
• Stock options awards
• Employee Stock Purchase Plan (ESPP)
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program, including onsite gym and mindfulness classes

Before you apply

• Candidates must reside in the San Francisco Bay Area.
• No relocation offered.

About the company

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells.