Design Quality Assurance Specialist
3 weeks ago
Nevro is a global medical device company headquartered in California, focused on delivering comprehensive solutions for chronic pain treatment. Our proprietary 10 kHz Therapy has impacted the lives of over 100,000 patients worldwide.
Our Comprehensive Platform
Nevro's HFXTM spinal cord stimulation platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Our Senza, Senza II, Senza OmniaTM, and Senza HFX iQTM systems deliver Nevro's proprietary 10 kHz Therapy, with HFX iQ being the first and only SCS System to use Artificial Intelligence for optimized pain relief.
Job Summary & Responsibilities
The Software Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing, with an emphasis on design controls pertaining to software development. This role involves applying knowledge of software design and development, software verification, and quality principles and practices for implantable medical devices and accessories.
Key Responsibilities
• Follow procedures to guide software and systems development and ensure 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.
• 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.
Requirements
• 5+ years of Quality/Regulatory experience in a medical device or other regulated industry.
• Bachelor's degree in a technical or science major.
• 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.
• 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.
What We Offer
Nevro offers a comprehensive benefits package, including market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.
EEO Statement
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, protected veteran status, disability, age or other characteristics protected by laws.
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