Senior Enterpise Software Test Engineer

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the LifeMedtronic is seeking a motivated and detail-oriented Sr. SOUP Engineer to join our Affera Mapping and Ablation System team. This role is essential in supporting the testing and quality assurance processes to ensure the reliability and performance of our advanced medical devices. You will be an integral member of the Affera Software Team, working on cutting-edge technology in the electrophysiology field.
In this role, you will lead the identification, specification, risk assessment, validation, and lifecycle management of Software of Unknown Provenance (SOUP) used in regulated medical device products.
You will work across Software Engineering, Systems Engineering, Verification and Validation (V&V), Risk Management, Cybersecurity, Supplier Quality, Quality Assurance, Legal, and Regulatory teams to ensure third-party and open-source software is appropriately selected, documented, validated, traceable, secure, and release-ready.
The ideal candidate combines strong software engineering judgment with hands-on experience in medical device software lifecycle processes, requirements and test traceability, risk management, software bills of materials (SBOMs), and controlled technical documentation.

Responsibilities may include the following and other duties may be assigned.

• Lead SOUP activities throughout the product lifecycle in accordance with IEC 62304, applicable regulatory guidance, quality-system procedures, and industry best practices.
• Establish and maintain a complete inventory of commercial, open-source, and other third-party software components, including versions, intended use, origin, licenses, and operating environments.
• Develop and maintain SOUP specifications covering functional, performance, interface, and computing-environment requirements with objective acceptance criteria.
• Assess existing SOUP records and remediate documentation or evidence gaps using approved controlled-document processes.
• Support software safety classification and determine the appropriate level of SOUP documentation using a risk-based approach.
• Integrate SOUP failure modes, known anomalies, and potential hazardous situations into product software risk analyses.
• Develop validation strategies and map SOUP requirements to unit, integration, and system verification evidence.
• Review test protocols and reports for adequacy, identify coverage gaps, and coordinate additional testing or residual-risk documentation.
• Prepare and maintain SOUP validation reports, traceability matrices, version baselines, and release-readiness evidence.
• Maintain alignment between SOUP records, the software architecture, software requirements, release documentation, and the product SBOM.
• Perform or coordinate known-defect, vulnerability, and supplier anomaly reviews, particularly for safety-critical SOUP.
• Assess new SOUP components and version changes for risk, cybersecurity, licensing, supplier-quality, and re-validation impacts.
• Coordinate commercial software assessments with Supplier Quality and open-source license reviews with Legal.
• Support design reviews and release-readiness reviews by confirming validation status, SBOM accuracy, known-defect analysis, vulnerability disposition, and license compliance.
• Establish sustainable workflows for periodic SOUP review, maintenance, issue management, and post-market monitoring.
• Provide technical leadership, mentor engineers, facilitate cross-functional reviews, and deliver process training and knowledge transfer.
• Support internal audits, external audits, regulatory submissions, and responses related to SOUP and third-party software controls.

Required knowledge and Experience:

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field.
• Typically 7+ years of relevant experience in software engineering, software quality, systems engineering, V&V, or product development.
• At least 3 years of experience supporting software for regulated medical devices or another highly regulated industry.
• Demonstrated knowledge of IEC 62304 and risk-based medical device software lifecycle practices.
• Experience specifying, assessing, validating, or maintaining third-party, open-source, OTS, or SOUP software.
• Strong experience with software requirements, test methods, verification reports, and bidirectional traceability.
• Experience creating controlled technical documents such as validation plans and reports, specifications, risk analyses, and traceability matrices.
• Working knowledge of software risk management and the relationship between software failures, hazardous situations, risk controls, and verification evidence.
• Experience reviewing SBOMs, software dependencies, known defects, published anomalies, or cybersecurity vulnerabilities.
• Ability to interpret software architecture, dependency information, build records, test evidence, and release documentation.
• Strong written communication, technical-review, problem-solving, and cross-functional leadership skills.

  Nice to have:

• Experience applying regulatory guidance for off-the-shelf software used in medical devices.
• Familiarity with ISO 14971, IEC 81001-5-1, FDA cybersecurity guidance, and secure product development practices.
• Experience with Class B or Class C medical device software.
• Experience with embedded, cloud-connected, mobile, diagnostic, therapeutic, or other complex medical device software.
• Familiarity with common operating systems, programming languages, open-source ecosystems, software libraries, hardware drivers, and networked systems.
• Experience with Jira, requirements-management tools, document-control systems, source control, dependency scanning, or SBOM platforms.
• Experience evaluating open-source licenses and coordinating supplier assessments for commercial software.
• Prior experience leading a process transition, remediation program, audit response, or regulated-software documentation migration.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).