Software Quality Engineer II (Medtech)

TL;DR

Software Quality Engineer II (Medtech): Driving quality for design, development, and maintenance of software for Affera cardiac electrophysiology systems with an accent on regulatory compliance and risk analysis. Focus on ensuring reliability standards for therapy software and collaborating with cross-functional teams to improve patient outcomes.

Location: Must be based in Mounds View, Minnesota, USA. Work format is hybrid with a minimum of 4 days a week onsite.

Salary: $81,600 - $122,400

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Support software quality and reliability for Cardiac Ablation Solutions, ensuring compliance with FDA CFR, MDR, IEC 62304, and ISO 13485.
• Perform software risk analysis and maintain comprehensive risk files to ensure system safety.
• Review and approve Design History File documents, including requirements, design, integration, and test protocols.
• Collaborate with R&D, medical safety, and regulatory affairs teams to align on quality requirements.
• Track software quality metrics and recommend design or test improvements to increase product reliability.
• Provide software quality support for post-market activities, including defect and health risk assessments.

Requirements

• Bachelor's degree with 2+ years of relevant experience OR a Master's degree.
• Unrestricted U.S. work authorization is required; no immigration sponsorship is available for this role.
• Proven ability to write, read, and interpret software code to collaborate effectively with engineers.
• Experience creating risk analysis documentation, such as FMEAs and FTAs.
• Experience in medical device or other regulated industries (e.g., defense or aerospace).
• Ability to travel up to 15% as required.

Nice to have

• Experience with Python, Linux, Docker, AWS, REST APIs, React, and/or Flutter/Dart.
• Knowledge of cybersecurity and the software lifecycle within regulated environments.
• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ).
• Experience with cardiac/electrophysiology medical specialties.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and a global well-being program.
• Employee Stock Purchase Plan and tuition reimbursement.
• Long-term disability leave and dependent daycare spending accounts.