Software Quality Assurance Engineer
Company: NeuroPace
Location: Mountain View
Posted on: April 2, 2021
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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
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