Medtech Software QA Engineer I – Quality & Compliance

Medtronic plc

Mounds View (MN)

On-site

USD 65,000 - 97,000

Full time

3 days ago

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Benefits offered by this job

Health, dental and vision insurance

401(k) with employer match

Tuition assistance/reimbursement

Employee stock purchase plan

Job summary

Medtronic plc in Minnesota (Mounds View) is seeking a Software Quality Engineer to join the Affera cardiac electrophysiology software team. You will drive quality for design, development, and post-market support, ensuring compliance with FDA CFR, MDR, IEC 62304, and ISO 13485 while collaborating with R&D, regulatory affairs, and clinical teams.

The role emphasizes hands-on time in engineering labs, risk analysis, documentation review, and contribution to quality metrics.

Qualifications

Bachelor's degree and minimal relevant experience; must be able to write new software code and read/understand existing code to collaborate with software engineers.
Experience with or understanding of regulated environments and cybersecurity is preferred.
Experience with Python, Qt, Docker, and Linux is desirable.

Responsibilities

Support software quality efforts ensuring compliance with regulatory standards (FDA CFR, MDR, IEC 62304, ISO 13485).
Collaborate with quality and extended teams to meet program deadlines and ensure traceability of design history files.
Perform risk analysis activities and support post-market activities including defect assessments and CAPAs.
Review Design History Files and ensure documentation meets reliability and QMS standards.