Principal Software Quality Engineer

NeuroPace•Mountain View, CA

3h•$124 - $165

About The Position

Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive. We are currently seeking a Principal Software Quality Engineer to join our team. This will be an individual contributor role working collaboratively with the Quality Design Assurance Engineering team, Product Development, Product Monitoring, IT and Clinical Research teams on product design development through the product development lifecycle

Requirements

BS degree in a recognized engineering discipline, preferably Software Engineering.
10 years’ minimum experience as a quality professional, in the medical device industry.
Demonstrated working knowledge of FDA QSR, ISO 13485, ISO 62304, ISO 62366, MDSAP, and MDR.
Excellent verbal and written skills, interpersonal skills.

Nice To Haves

ASQ certifications desired, but not necessary.

Responsibilities

Participate in project teams and provide guidance to the team on software quality related activities (product software and firmware) assuring adherence to the software development lifecycle which may include PCCP strategy development. Assure that design controls are met; project plans include relevant software deliverables, and objective, measurable and verifiable customer and product requirements are established. Support establishment and adherence of project schedules.
Update processes, implement templates, and mentor users in ensuring compliance with FDA QSR Part 820, ISO 13485, ISO 62304 and ISO 62366.
Ensure compliance with software risk standards by participating in risk management activities and ensuring compliance with risk management documentation, such as software risk analyses, safety analyses, communication analyses, sFMEA.
Ensure compliance with cybersecurity procedures and standards. Ensure that software risk analyses include cybersecurity risks and define processes for threat modeling. Assist in the writing of cybersecurity risk management reports.
Assess algorithmic design and implementation for robustness, bias, and adherence to regulatory requirements. Ensure proper validation and verification of AI-driven features, including transparency and explainability of models.
Ensure compliance with SaMD regulatory landscape.
Assure that software architecture is properly established and challenge software architectures/ designs and requirements for adequacy, safety, and robustness.
Review software verification plans, protocols and reports for compliance with procedures and regulations.
Apply usability engineering knowledge during applicable analyses and reviews.
Represent Quality on the Software Change Board (SCB).
Verify and implement laptop and tablet PC replacements to support manufacturing.
Assess data and analytics as needed.
Support audits by global regulators to support ISO 13485, MDSAP, Health Canada and CE Mark audits.