Principal Software Quality Engineer, Redwood City, CA (Onsite role)
US-CA-Redwood City
Job ID: 2025-4957
Type: Regular Full-Time
Category: Quality
HQ
Overview
The Principal Software Quality Engineer is responsible for Quality Assurance activities ranging from software product development (PD) to design transfer, through to sustaining, and then obsolescence. This is a hands-on role where the Principal Software Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for software design and development per 62304 for implantable medical devices and accessories. Will work independently with little to no supervision and exercise considerable discretion in determining objectives and approaches to significant organizational PD projects or assignments. The role will have responsibility for ensuring compliance to process/procedures related to software design and development, risk management, and external standards on topics including cybersecurity and SDLC. This position will report to Director, Quality Engineering.
- Follow procedures to guide software and systems development and ensure best engineering practice compliance with relevant regulatory requirements
- Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
- Software Design Control Documentation
- Software-related Product specification and Device Master Record
- Systems and/or sub-systems software design verification & validation activities
- Cybersecurity Assessment
- Risk Management
- CAPA /NCMR
- External Standards and Regulatory Audits
- Quality Investigations (CAPA, SW Anomalies)
- Traceability
- Participate in cybersecurity, post market vulnerability assessments, HHEs and other risk management processes
- Support internal and external regulatory audits, regulatory submissions, and other quality assurance functions.
- Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.
- Demonstrate understanding of software best practices and promote implementation into the quality system.
- Work with departments to discuss system gaps, fixes, design solutions and risks.
- Project leader on various projects by representing Quality Assurance
- Provide concise updates of critical projects to Senior Management.
- Perform other duties as required
Responsibilities- 8+ years of Quality /Regulatory experience in a medical device or other regulated industry
- Bachelor's degree in a technical or science major
Qualifications- 8 years’ experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- Master’s Degree preferred.
- Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
- Experience working with Cloud based infrastructure and systems that process, store, and distribute large sets of data continuously.
- Experience with Medical Device Firmware/Software Development
- FDA Software guidance of Verification & Validation
- Active Implantable Medical Device Directives (90/385/EEC)
- Strong understanding and working knowledge of IEC 62304, EN ISO 14971, FDA Software Guidance or similar standards
- Understanding and working familiarity with AAMI TIR 57, AAMI TIR 97, IEC 81001-5-1, IEC 30111.
- Project management skills; capable to lead project teams.
- Highly developed written and oral communication skills and strong collaborator able to guide and influence partnered engineering teams.
- Must have good problem-solving skills and be able to work independently
- Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation
- Must be organized, detail-oriented and adaptable according to evolving situations at hand.
- ASQ Certified Software Quality Engineer (CSQE) and/or Six Sigma Green/Black belt preferred.
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Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.
Equal employment opportunity, including veterans and individuals with disabilities.
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