Principal Software Quality Engineer

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

Key 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. 

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. 
• ASQ certifications desired, but not necessary. 

 

$124-$165K Base - Compensation will be determined based on several factors, including but not limited to skill set, years of experience and geographic location.

NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

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