Senior Software Quality Engineer
US-CA-Redwood City
Job ID: 2025-4868
Type: Regular Full-Time
Category: Quality
HQ
Overview
The Sr. Software Quality Engineer is responsible for the design and development Quality Assurance activities related to new software products. This is a hands-on role where the Sr. Software Quality Engineer will apply diversified knowledge of software design and development as per 62304, software verification, recognized software development standards and quality principles and practices for implantable medical devices and accessories. This position will report to Associate 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:
- Risk Management
- Cyber security Risk assessment
- Systems Validation
- Quality Investigations
- Traceability
- Software Design
- Participate in cybersecurity, post market vulnerability assessments and other risk management processes
- Support internal and external regulatory audits, 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
- Work with departments to discuss system gaps, fixes, design solutions and risks.
- Perform other duties as required
Responsibilities- 5+ years of Quality /Regulatory experience in a medical device or other regulated industry
- Bachelor's degree in a technical or science major
Qualifications- 3 years’ experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- Proficiency in at least one software language (e.g., C++, C#, or Swift), with exposure to iOS (Swift) or C/C++ firmware being a plus.
- 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.
- FDA Software guidance of Verification & Validation
- Active Implantable Medical Device Directives (90/385/EEC)
- Understand and working knowledge of IEC 62304, EN ISO 14971, AAMI TIR 57, AAMI TIR 97, IEC 60601-4-5, IEC 62443-3-1, IEC 30111, FDA Software Guidance or similar standards,
- Highly developed written and oral communication skills and be able to work in a team environment
- 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) preferred.
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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