Software Quality Assurance Engineer

Company: NeuroPace
Location: Mountain View
Posted on: April 2, 2021

Job Description:

Job Responsibilities:1. Effective at applying quality engineering to software development, design changes, and manufacturing.--Good team player.--Perform the following types of tasks as needed, ensuring compliance with industry standards and regulatory requirements: -- Support design verification and validation efforts through writing of plans, protocols and reports per project schedules. Support software verification and validation design and technical reviews. Participate on project teams and provide guidance to the team on software quality related activities.--Assist with software code reviews and requirements writing when needed.-- Write and execute software verification protocol and reports.--Rewrite verification protocols to make them executable by an uninitiated engineer. When possible, automate software verifications to reduce project timelines and increase software quality.--As needed, write and execute non-product Software validation protocols.-- Participate in risk management activities and assist in the management and maintenance of risk management documentation, such as risk analyses, safety analyses, communication analyses, etc. Facilitate product software risk analyses including cybersecurity risks.-- Suggest and implement improvements to the Software Development Process to improve efficiency and robustness. -- Apply usability engineering knowledge during applicable analyses, reviews.-- Resolve manufacturing software problems, and address non-conformances.-- Complies with quality system requirements and assesses quality and business processes.2. Verify and implement Dell laptop and tablet replacements to support manufacturing.3. Participate as a member of the engineering change board, ensuring that released parts and documents are accurate and complete; and ensuring that supporting documentation is adequate. Initiate changes to release V&V and production software, software image changes, new tablets/laptops, etc.4. Update and maintain the Software Development SOP, Non-Product Software Validation SOP, and other quality system documents, as needed.5. Mentors junior engineers as required.Requirements:1. BS degree in a recognized engineering discipline, preferably Software Engineering 2. 5 years minimum experience as a quality professional in a medical device or related industry3. Highly desirable: Applies FDA Quality System Regulations and ISO 13485:2016.--Familiarity with Medical Device Regulations, ISO 9001:2015, and knowledge of IEC 62304 is a plus. 4. Highly desirable: Experience in product manufacturing & development, project management5. Preferred: Experience with software test automation tools Essential: Excellent interpersonal skills, both written and verbal

Keywords: NeuroPace, Mountain View , Software Quality Assurance Engineer, IT / Software / Systems , Mountain View, California