Principal Software Quality Engineer - Infrastructure/Post-Market (Medtech)

TL;DR

Principal Software Quality Engineer - Infrastructure/Post-Market (Medtech): Drive post-market software issue evaluations, health risk analyses, and compliance for Affera cardiac electrophysiology systems with an accent on real-world clinical performance, regulatory alignment, and cross-functional risk management. Focus on leading CAPA activities, authoring audit-ready documentation, and influencing enterprise-level quality processes.

Onsite Mounds View, Minnesota, United States. Minimum 4 days a week onsite required. Travel <20%.

Salary: $124,800 - $187,200 USD

Company

Global healthcare technology leader with 95,000+ employees focused on alleviating pain, restoring health, and extending life.

What you will do

• Build deep system-level understanding of Affera software through live case observations and field issue analysis.
• Lead post-market issue evaluations, complaint analysis, risk assessments, and impact determination.
• Author Health Risk Assessments linking software anomalies to system impacts and risk files.
• Guide CAPA root cause analysis, mitigation, and effectiveness verification as quality authority.
• Author and approve post-market documentation ensuring FDA, EU MDR, and global regulatory compliance.
• Drive field corrective actions, track metrics, and provide program management support.
• Represent post-market quality in audits, inspections, and cross-functional reviews.

Requirements

• Bachelor's degree + 7 years relevant experience OR Master's + 5 years OR PhD + 3 years
• Unrestricted U.S. work authorization required (sponsorship available for Principal-level)
• Ability to secure hospital credentialing for clinical site visits
• Strong analytical, communication, and technical data evaluation skills

Nice to have

• Degree in software, computer, electrical, or biomedical engineering
• 7+ years in software quality, post-market surveillance, or regulated medical devices
• Knowledge of FDA CFR, MDR, ISO 13485, IEC 62304
• Experience with FMEAs, FTAs, cardiac electrophysiology devices
• Quality/regulatory certifications (ASQ, Six Sigma)

Culture & Benefits

• Minimum 4 days/week onsite to foster collaboration and growth
• Competitive salary, hirify.global Incentive Plan (MIP), 401(k) with match
• Health, dental, vision insurance; HSA, FSA, life insurance, LTD
• Paid time off, holidays, tuition reimbursement, employee stock purchase
• Employee Assistance Program, global well-being program