Senior Software Quality Engineer (Medical Devices)

TL;DR

Senior Software Quality Engineer (Medical Devices): Driving quality for the design, development, and maintenance of software for Affera cardiac electrophysiology systems with an accent on regulatory compliance and product reliability. Focus on reviewing Design History File documents, performing risk analysis, and ensuring adherence to FDA and ISO standards.

Location: Onsite in Mounds View, Minnesota, USA (minimum 4 days a week onsite)

Salary: $102,400 - $153,600

Company

Global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Ensure software quality and reliability compliance with FDA CFR, MDR, IEC 62304, and ISO 13485 standards.
• Review and approve Design History File documents, including requirements, design, test protocols, and reports.
• Conduct software risk analysis and defect assessments to improve product reliability and security.
• Support post-market activities, including issue assessments, health risk assessments, and CAPAs.
• Collaborate with R&D, regulatory affairs, and clinical teams to align on quality requirements.
• Participate in live electrophysiology cases to enhance workflow and product knowledge.

Requirements

• Bachelor's degree with 4+ years of experience, Master's with 2+ years, or a PhD.
• Unrestricted U.S. work authorization required (sponsorship is only offered for Principal-level roles and above).
• Experience in the medical device industry or other regulated sectors like defense or aerospace.
• Ability to read and interpret software code to effectively collaborate with software engineers.
• Strong knowledge of cybersecurity and the software lifecycle within regulated environments.

Nice to have

• Experience with Python, Qt, Docker, and Linux.
• Experience creating risk analysis documentation such as FMEAs and FTAs.
• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ).
• Experience with cardiac and electrophysiology medical specialties.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Tuition assistance and reimbursement programs.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Employee Stock Purchase Plan and Incentive plans (MIP).