Senior Software Systems Engineer - Medical Device Quality

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

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Dependent daycare spending account

Tuition assistance/reimbursement

Simple Steps (global well-being)

Job summary

Medtronic seeks a Senior Software Systems Engineer to join the Neuromodulation and Pelvic Health Premarket Design Quality team. You will ensure software and system-level design activities comply with quality and regulatory requirements throughout the design control lifecycle.

Responsibilities include providing design quality support, reviewing requirements, developing verification/validation strategies, and mentoring engineers to enhance product quality, safety, and compliance across

Qualifications

• Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field with minimum 4 years of relevant experience OR Master's with 2+ years OR PhD with 0+ years.
• Demonstrated experience with design controls, software development lifecycle activities, and verification/validation.
• Strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing.
• Experience supporting cross-functional product development teams

Responsibilities

• Provide design quality support for software and software-enabled medical device development programs from concept through transfer to manufacturing.
• Ensure compliance with applicable design control, software lifecycle, and risk management requirements.
• Review and contribute to system requirements, software requirements, architecture, and design documentation.
• Participate in the development of verification and validation strategies for software, system, and integration testing.
• Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
• Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
• Lead software-related risk evaluation and mitigation verification to support risk management activities, including hazard analysis
• Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.
• Assist in root cause analysis and corrective action activities related to design or software quality issues.
• Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.
• Contribute to continuous improvement initiatives for design quality processes, tools, and templates.

Skills

Design controls

Software lifecycle

Risk management

Cross-functional collaboration

Education

Bachelor's degree in a related technical field

Master's degree in a related field

PhD in a related field

Job description

Medtronic seeks a Senior Software Systems Engineer to join the Neuromodulation and Pelvic Health Premarket Design Quality team. You will ensure software and system-level design activities comply with quality and regulatory requirements throughout the design control lifecycle.

Responsibilities include providing design quality support, reviewing requirements, developing verification/validation strategies, and mentoring engineers to enhance product quality, safety, and compliance across