Principal Software Quality Engineer

Pulse Biosciences•Hayward, CA

2d•Onsite

About The Position

Pulse Biosciences is a bioelectric medicine company developing its proprietary CellFX® nsPFA™ technology, which uses nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue. The company is pursuing applications in surgical treatment of atrial fibrillation and selected other markets. The Principal Software Quality Engineer is responsible for software quality assurance activities related to software and system development, verification, validation, functionality, and reliability of the CellFX system and accessories. The role supports research and development, manufacturing, regulatory, clinical investigation, and commercial activities, as well as quality-system development and regulatory filings. The position is onsite in Hayward, California, and candidates must reside in the San Francisco Bay Area. No relocation is offered. Travel may be up to 10%, including overnight or international travel.

Requirements

Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or a related field.
10 or more years of hands-on experience in software quality assurance, software testing, and/or software development.
At least 5 years of experience working with complex energy-based medical-device systems and Class III devices with software.
Familiarity with quality disciplines, tools, and methodologies.
Working experience with FDA software validation and cybersecurity guidance and IEC 62304 software lifecycle requirements.
Working knowledge and experience in design control, design and process validation, risk management, cybersecurity, quality-system compliance, complaint handling, MDR/vigilance reporting, and CAPA.
Knowledge of ANSI/AAMI/IEC 62304:2006, IEC 60601-1, IEC 60601-1-2, and ISO 14971:2019, including cybersecurity practices and implementation.
Strong oral and written communication skills, including experience writing technical documentation, test protocols, and test reports.
Project management skills and the ability to independently manage critical projects as part of an interdisciplinary team and meet deadlines.
Hands-on experience preparing, managing, and submitting major regulatory submissions.
Ability to work conscientiously with minimal direction, use good judgment, take initiative, and recommend actions.
Ability to work as a team member, multitask, and adapt to changing priorities and requirements.
Proficiency with Microsoft Office Suite applications.
Ability to travel up to 10% of the time; overnight and/or international travel may be required.
Ability to lift 10–15 pounds.
Must reside in the San Francisco Bay Area; the position is onsite in Hayward, California.

Nice To Haves

Experience with cardiovascular devices is preferred.
Background in software test development, test methodologies, and test automation for native applications built on QNX or a similar operating system.

Responsibilities

Provide software quality assurance, design-controls, and compliance expertise to product development and manufacturing teams.
Develop, establish, and maintain software quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.
Investigate, identify, and implement software quality engineering practices and process controls for product development, qualification, and ongoing manufacturing.
Develop and validate software methods, monitor medical-device software standards, and facilitate and perform software code reviews.
Assist with regulatory submissions and assessments related to software changes and cybersecurity.
Develop software standard operating procedures, test methodologies, and software verification and validation protocols and reports.
Design and implement methods and procedures for software release, field upgrades, and final quality assurance.
Work with the Software Development Team to plan, schedule, and improve development test processes.
Collaborate with engineers, developers, and end users to understand and validate business requirements, working with minimal supervision.
Perform validation and verification testing of medical devices and equipment in an FDA-regulated environment.
Support internal quality audits, management reviews, Notified Body audits, and FDA QSIT audits.
Assist with product labeling, translation, and investigator brochures for commercial and clinical studies.
Supervise employees as assigned.
Carry out responsibilities in accordance with organizational policies and applicable laws.
Support the Pulse Biosciences Quality Policy and Quality System.