200+ applicants

Company

Nevro · 2 days ago

Design Quality Engineer III

Redwood City, CA

Full-time

Remote

Mid, Senior Level

$89K/yr - $123K/yr

5+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

Hiring Manager

Joy Simpson

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Responsibilities

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, Configuration management

Lead 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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality AssuranceFDA regulationsISO 13485Software Development Life CycleAgile Software DevelopmentWaterfall ModelCloud InfrastructureCybersecurityCorrective Action & PreventionASQ Certified Software Quality Engineer

Required

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

Highly developed written and oral communication skills and be able to work in a team environment

Good problem-solving skills and be able to work independently

Working knowledge of Corrective Action & Prevention methodology

Organized, detail-oriented and adaptable according to evolving business needs

Preferred

ASQ Certified Software Quality Engineer (CSQE)

Benefits

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

Several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion

Company

Nevro

Glassdoor

3.7

Nevro provides pain relief solutions for patients suffering from low back pain and other types of chronic pain. It is a sub-organization of Nevro.

Founded in 2006

Menlo Park, California, USA

1,001-5,000 employees

http://www.nevro.com

H1B Sponsorship

Nevro 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

2023 (7)

2022 (21)

2021 (7)

2020 (11)