Senior Software Systems Engineer – Medical Devices (On‑Site)

Medtronic plc; Fridley (MN); On-site; USD 121,000 - 181,000; Full time

Job summary

Medtronic plc in Fridley, Minnesota invites applications for a Senior Software Systems Engineer in Neuromodulation and Pelvic Health Premarket Design Quality. You will provide design quality oversight across software-driven medical devices, ensuring regulatory compliance, risk management, and traceability throughout the development lifecycle.

The role collaborates with engineering, regulatory, clinical, and manufacturing teams to advance patient care while mentoring colleagues and driving

Qualifications

• Experience with design controls, software lifecycle activities, and verification/validation.
• Strong understanding of risk management principles, design failure analysis, and traceability across requirements, design, and testing.
• Experience supporting cross-functional product development teams.
• Familiarity with IEC 62304, ISO 14971, ISO 13485, FDA design control expectations.

Responsibilities

• Provide design quality support for software-enabled medical device development from concept through transfer to manufacturing.
• Ensure compliance with design control, software lifecycle, and risk management requirements.
• Review system and software requirements, architecture, and design documentation."
• Lead verification/validation strategies for software, system, and integration testing.

Skills

Design controls

Software lifecycle

Risk management

Regulated industry

Education

Bachelor's degree in engineering or related field

Master's degree with 2+ years experience or PhD

Job description

Medtronic plc in Fridley, Minnesota invites applications for a Senior Software Systems Engineer in Neuromodulation and Pelvic Health Premarket Design Quality. You will provide design quality oversight across software-driven medical devices, ensuring regulatory compliance, risk management, and traceability throughout the development lifecycle.

The role collaborates with engineering, regulatory, clinical, and manufacturing teams to advance patient care while mentoring colleagues and driving