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Mobile Device Quality Engineer Jobs (NOW HIRING)

Heartflow

Senior Device Quality Engineer

San Francisco, CA · Hybrid

$160K - $180K/yr

As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical ...

GSK

$75K - $101K/yr

The Senior Device Quality Engineer provides quality and compliance leadership for manufacturing and packaging equipment at the Zebulon, NC site, ensuring systems and processes used to produce ...

GlaxoSmithKline

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to operations, engineering, and quality teams. Why You? We seek clear communicators who care about quality and ...

Socket.dev

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical ...

GSK

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to operations, engineering, and quality teams. Why You? We seek clear communicators who care about quality and ...

Biopharma Careers

Senior Device Quality Engineer

Zebulon, GA · On-site

$79K - $107K/yr

Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to operations, engineering, and quality teams. Why You? We seek clear communicators who care about quality and ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical ...

CSL Plasma Inc.

$115K - $136K/yr

The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on ... Experience with products that include embedded software, mobile / web apps and other connected ...

Synkriom

Be Seen First

Medical Device Quality Engineer

Warsaw, IN · On-site

$35 - $40/hr

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred Company Description Founded in 2015 and backed by two decades of hands-on experience, our ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

System One

Mobile Device Engineer II

Washington, DC · On-site

$38.44/hr

Mobile Device Engineer II Location: Washington, DC Type: Contract To Hire Compensation: $38.44 (Pay ... We help clients get work done more efficiently and economically, without compromising quality.

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

System One

Mobile Device Administrator

Rockville, MD · On-site

Mobile Device Administrator Rockville, MD - Hybrid Rate Negotiable Contract : * Mobile Device support and troubleshooting, including o Device Procurement (Phones, Tablets & Hotspot/MiFi) via DHHS ...

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Mobile Device Quality Engineer information

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How much do mobile device quality engineer jobs pay per year?

As of Sep 11, 2026, the average yearly pay for mobile device quality engineer in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

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For Mobile Device Quality Engineer jobs, the most frequently searched job titles are:

Senior Device Quality Engineer

San Francisco, CA • Hybrid

Heartflow
Medical Equipment and Supplies Manufacturing • 201 - 500 employees
Learn more about Heartflowexternal

$160K - $180K/yr

Full-time

Posted 28 days ago

HeartFlow rating

7.2

Company rating: 7.2 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

As the Senior Device Quality Engineer, you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions-including Software as a Medical Device (SaMD) and AI/ML-enabled technologies-are safe, secure, and compliant.

Your core responsibility will be the hands-on management of the end-to-end design control process within Heartflow's Software Development Lifecycle (SDLC). You will ensure that software architecture, security, and global regulatory requirements are integrated into every release.

Key Responsibilities

Technical Leadership

  • Standards Execution: Apply global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities.
  • SDLC Support: Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
  • Agile Integration: Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases.

Design Quality & Risk Management

  • Design Reviews: Participate in software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles.
  • Risk Analysis: Facilitate and document comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
  • V&V Execution: Act as the lead for Software Verification and Validation (V&V); develop and execute test strategies, protocols, and reports to ensure product performance.

Execution & Compliance

  • DHF Ownership: Manage the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless.
  • Audit Support: Support the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a subject matter expert for software processes.

Cross-Functional Collaboration

  • Technical Documentation: Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR.
  • Team Guidance: Provide technical coaching and quality training to R&D and Product teams to foster a culture of compliance.

Skills Needed

  • Strong critical thinking skills and great attention to detail.
  • Ability to work as a self-starter in a fast-paced, adaptive environment.
  • Excellent communication, documentation, and time management skills.

Educational Requirements & Work Experience

  • Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
  • 5-8 years of experience in quality engineering or product development within the medical device industry.
  • Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.

This position has an estimated base salary of $160,000 - $180,000, bonus. #LI-IB1; LI-Hybrid

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