About the Role

The Principal Software Quality Engineer will be responsible for quality assurance activities related to software/system development, verification, validation, and overall system functionality and reliability of the CellFX system and accessories in support of the Company’s research and development, manufacturing, regulatory, clinical investigations, and commercial efforts. In addition, this position will support the development and implementation of quality systems and regulatory filing activities.

To Make an Impact, You Will:

• Provide expertise and guidance to product development and manufacturing teams in the areas of SW quality assurance, design controls and compliance.
• Develop, establish and maintain SW quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
• Proactively investigate, identify and implement best-in-class SW quality engineering practices.
• Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
• Develop and validate SW methods, monitor medical device SW standards, facilitate and perform SW code review.
• Assist with preparation of regulatory submissions, regulatory assessments related to software changes and cybersecurity.
• Development of SW standard operating procedures, SW test methodologies, and software verification & validation protocols and reports.
• Design and implement methods and procedures for SW release, SW field upgrade, and final quality assurance.
• Work closely with the Software Development Team to plan, schedule, and improve development test processes.
• Work well in a collaborative team environment with other engineers, developers and end users with minimal supervision and ensure understanding and validation of business requirements.
• Perform validation and verification testing of medical devices and equipment in an FDA regulated environment.
• Support internal quality audits, management review activities, Notified Body audits (ISO), and FDA QSIT audits.
• Assist with development of product labeling, translation, and investigator brochures for commercial and clinical studies.
• Supervise employees as assigned.
• Carry out responsibilities in accordance with the organization’s policies and applicable laws.
• Support the Pulse Biosciences Quality Policy and Quality System.

To Excel, You Will Bring:

• 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 with at least 5+ years working with complex energy-based medical device system and Class III devices with SW. Cardiovascular devices are preferred.
• 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
• Must have working knowledge and experience in the following areas: Design Control, Design & Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA program.
• 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.
• The ideal candidate will have background in software test development, test methodologies and test automation for native applications built QNX or Similar OS.
• Good communication skills, including experience writing technical documentation, test protocol, test reports, etc.
• Must have excellent oral and written communication and project management skills
• Proven ability to independently manage critical projects as part of an interdisciplinary team and navigate challenges to deadlines.
• Hands-on experience preparing, managing and submitting major regulatory submissions.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• Proficient knowledge and skill in 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.

Pay Range:

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $165k-$200k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.