Senior Software Systems Engineer – Premarket Design Quality

Regulatory Jobs; Fridley (MN); On-site; USD 121,000 - 181,000; Full time

Job summary

Medtronic is seeking a Senior Software Systems Engineer to join the Neuromodulation and Pelvic Health Premarket Design Quality team, driving software and system-level design activities in compliance with quality and regulatory requirements.

The role provides quality oversight across the design control lifecycle, delivering guidance on software-intensive medical device development, risk management, and verification/validation while collaborating with cross-functional teams to ensure regulatory

Qualifications

• Bachelor's degree in a technical field with minimum 4 years of relevant experience, or master's/PhD with varying years as stated.
• Strong experience with design controls, software lifecycle activities, and verification/validation.
• Solid understanding of risk management principles and traceability across requirements, design, and testing.

Responsibilities

• Provide design quality support for software and software-enabled medical device development from concept through transfer to manufacturing.
• Ensure compliance with design control, software lifecycle, and risk management requirements.
• Review and contribute to system/software requirements, architecture, and design documentation.
• Support verification and validation strategies for software, system, and integration testing.
• Collaborate with engineering, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
• Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
• Assist in risk management activities including hazard analysis and mitigation verification.
• Participate in design reviews and provide feedback to improve quality, safety, and compliance.
• Mentor junior engineers on design quality practices and documentation expectations.

Skills

Design controls

Software development lifecycle

Risk management

Regulatory compliance

Education

B.S. in Engineering / Software

Job description

Medtronic is seeking a Senior Software Systems Engineer to join the Neuromodulation and Pelvic Health Premarket Design Quality team, driving software and system-level design activities in compliance with quality and regulatory requirements.

The role provides quality oversight across the design control lifecycle, delivering guidance on software-intensive medical device development, risk management, and verification/validation while collaborating with cross-functional teams to ensure regulatory