Principal Software Quality Engineer

Pulse Biosciences•Hayward, CA

2d•$165,000 - $200,000•Onsite

About The Position

The Principal Software Quality Engineer is responsible for quality assurance activities related to software and system development, verification, validation, and the 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 the development and implementation of quality systems and regulatory filings. The position provides software quality assurance expertise to product development and manufacturing teams, develops and maintains software quality engineering processes, and helps ensure compliance with customer and regulatory requirements. It works collaboratively with software developers, engineers, and end users, and supports audits, regulatory submissions, clinical and commercial documentation, and the company’s Quality System. The role may supervise employees as assigned. This is an onsite position in Hayward, California. Candidates must reside in the San Francisco Bay Area; relocation is not offered. Travel of up to 10% may be required, including overnight or international travel. The role may require lifting 10–15 pounds. The Northern California base salary range is $165,000–$200,000.

Requirements

Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or a related field.
10+ 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.
Experience with quality disciplines, tools, and methodologies.
Experience with FDA software validation and cybersecurity guidance and IEC 62304 software lifecycle process 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 medical device software lifecycle processes.
Knowledge of medical electrical safety and EMC standards, including IEC 60601-1 and IEC 60601-1-2, and risk assessment under ISO 14971:2019, including cybersecurity practices and implementation.
Strong oral and written communication skills, including experience writing technical documentation, test protocols, and test reports.
Excellent project management skills and the ability to independently manage critical projects within an interdisciplinary team and meet deadlines.
Hands-on experience preparing, managing, and submitting major regulatory submissions.
Ability to work conscientiously with minimal direction, exercise 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.

Nice To Haves

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

Responsibilities

Provide expertise and guidance to product development and manufacturing teams in software quality assurance, design controls, and compliance.
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.
Identify and implement process control systems 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 regulatory assessments related to software changes and cybersecurity.
Develop software standard operating procedures, software 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.
Perform verification and validation 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, translations, 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.