NeuroPace · 8 hours ago
Principal Software Quality Engineer
Mountain View, CA
Full-time
Onsite
Lead/Staff
$124K/yr - $165K/yr
10+ years expNeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy. They are seeking a Principal Software Quality Engineer to collaborate with various teams on product design development through the product development lifecycle, ensuring compliance with software quality standards and regulations.
Health CareManufacturingMedical DeviceNeuroscience
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
Qualification
Required
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
Preferred
ASQ certifications desired, but not necessary
Benefits
Medical, Dental & Vision Insurance
Voluntary Life
401K
RSU
529 plan
ESPP Program
Health & Wellness Program
Generous Paid Time Off plus eleven paid holidays
FSA & Commuter Benefits
Company
NeuroPace
NeuroPace develops and markets implantable devices for the treatment of neurological disorders.
51-200 employees
H1B Sponsorship
NeuroPace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$457.1MKey Investors
MidCap FinancialNational Institutes of HealthAccelmed
2025-06-04Post Ipo Debt· $75M
2025-02-14Post Ipo Equity· $74.8M
2021-06-30Grant· $9.3M
Leadership Team
Joel Becker
President and CEO
Lisa Andrade
Independent Director
Recent News
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2026-01-13
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2025-12-17
Company data provided by crunchbase