Senior Software Systems Engineer, Design Quality

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

Job summary

Medtronic, a global leader in healthcare technology, is seeking a Senior Software Systems Engineer in the Neuroscience Premarket Design Quality team. You will partner with cross-functional development teams to ensure software and system-level design activities meet quality and regulatory requirements across the design control lifecycle.

This role emphasizes quality oversight, risk management, verification and validation strategies, and mentoring engineers to uphold product safety and compliance.

Qualifications

• Bachelor's degree in software/engineering or related field with 4+ years experience.
• Experience with design controls and software lifecycle verification/validation.
• Strong cross-functional collaboration across disciplines and teams.

Responsibilities

• Provide design quality support for software and software-enabled medical device programs from concept to transfer to manufacturing.
• Ensure compliance with design controls, software lifecycle, and risk management requirements.
• Review system and software requirements, architecture, and design documentation.
• Develop verification and validation strategies for software, system, and integration testing.
• Collaborate with engineering, regulatory, clinical, manufacturing, and quality teams to resolve issues.
• Evaluate software deliverables for completeness and traceability.
• Lead risk evaluation and mitigation verification to support risk management activities.
• Participate in design reviews and provide constructive feedback.
• Assist root cause analysis and corrective actions for design or software quality issues.
• Mentor junior engineers on design quality practices and regulatory expectations.
• Contribute to continuous improvement of design quality processes and templates.

Skills

Design controls

Software lifecycle

Risk management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Software Engineering or related field

Master's degree in related field

PhD in related field

Job description

Medtronic, a global leader in healthcare technology, is seeking a Senior Software Systems Engineer in the Neuroscience Premarket Design Quality team. You will partner with cross-functional development teams to ensure software and system-level design activities meet quality and regulatory requirements across the design control lifecycle.

This role emphasizes quality oversight, risk management, verification and validation strategies, and mentoring engineers to uphold product safety and compliance.