Sr. Software Quality Engineer

Medtronic

Remote Actively hiring
Remote, USA · Mounds View South, MN Posted 18 days ago $103,200–$154,800 / year
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At a glance

AI generated

TL;DR

As a Senior Software Quality Engineer at Medtronic, you will join a dedicated team focused on enhancing cardiac electrophysiology systems by ensuring software quality and regulatory compliance. Your daily tasks include reviewing design history files, developing documentation for traceability and testability, and collaborating with cross-functional teams to maintain high standards of reliability and security. You will leverage Python, Qt, Docker, and Linux in your work while adhering to FDA CFR, MDR, IEC 62304, and ISO 13485 guidelines. With a background in medical device development or similar regulated industries, you’ll contribute to risk analysis documentation and support post-market activities, all while advancing global healthcare through cutting-edge technology.

Skills

Python Qt Docker Linux FMEA FTA ISO_13485 IEC_62304 MDR FDA_CFR Six_Sigma ASQ CI/CD PostgreSQL

What you'll do

  • Support software quality and reliability efforts to ensure compliance with FDA CFR, MDR, IEC 62304, and ISO 13485.
  • Review and approve Design History File documents for software and security, ensuring all documentation meets QMS processes.
  • Develop expertise in assigned products through hands-on lab time and product training.
  • Participate in risk analysis and defect assessments to improve software reliability.
  • Track software quality metrics to support continuous improvement of quality outcomes.
  • Provide post-market software quality support including issue assessments and CAPAs.

What we're looking for

  • At least 4 years of relevant experience or equivalent education.
  • Experience in medical device development or regulated industries like defense/aerospace.
  • Ability to read, interpret, and understand existing software code for collaboration with engineers.
  • Strong knowledge of cybersecurity and the software lifecycle in regulated environments.
  • Experience creating risk analysis documentation such as FMEAs and FTAs.
  • Familiarity with Python, Qt, Docker, and Linux.
  • Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ).

Market check

Salary context

This $103,200–$154,800 range sits above 11% of similar postings on FindRole.

Peer median band

$139,762–$214,950

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$150,000–$204,070

Middle half of comparable postings.

Based on 240 comparable postings.

* 240 is the maximum number of comparable postings sampled.

Employer

About Medtronic

Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.

Medtronic currently has 24 open roles on FindRole.

Listed pay typically runs $135,200–$198,000 across 24 roles with salary data.

Most-posted roles

View all roles at Medtronic

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