Software Quality Engineer II (Reliability/ Compliance) (Medical Devices)

Location: Onsite in Mounds View, Minnesota, United States; minimum four days per week onsite. Travel requirement: less than 15%.

Salary: $81,600–$122,400 annually, plus eligibility for a short-term incentive plan.

Company

hirify.global develops medical technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Support software quality and reliability for Cardiac Ablation Solutions and Affera cardiac electrophysiology products.
• Ensure compliance with FDA CFR, MDR, IEC 62304, ISO 13485, and quality management system processes.
• Participate in software risk analysis, defect and issue assessments, health risk assessments, CAPAs, and post-market activities.
• Review and approve software and security design history file documentation, including requirements, design, testing, verification, validation, and tooling records.
• Develop traceability, testability, quality metrics, and reliability strategies for assigned programs.
• Collaborate with R&D, medical safety, regulatory affairs, and clinical teams, including hands-on engineering lab work and live-case learning.

Requirements

• Bachelor’s degree with at least 2 years of relevant experience, or a master’s degree with at least 0 years of relevant experience.
• Proven ability to write software code and read, interpret, and understand existing code, although this is not primarily a coding role.
• Must be authorized to work in the United States without immigration sponsorship.
• Ability to work onsite at least four days per week in Mounds View, Minnesota.
• Experience supporting software quality, reliability, compliance, or regulated software development.

Nice to have

• Medical device or other regulated-industry experience, including defense or aerospace.
• Experience with FMEAs, FTAs, cybersecurity, and regulated software lifecycles.
• Experience with Python, Linux, Docker, Windows, AWS, REST APIs, React, or Flutter/Dart.
• Cardiac or electrophysiology experience, an advanced degree, or quality and regulatory certifications such as Six Sigma or ASQ.

Culture & Benefits

• Work in cross-functional teams focused on patient outcomes, quality, and medical technology.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and tuition assistance.
• Global well-being resources and incentive plans for eligible employees.