Systems Engineer - Software

Solu is seeking a Systems Engineer 20a Software to support our clients Product Definition team for an on-market product. This role focuses on software requirements, product risk management, and cross-functional collaboration to ensure product quality, safety, and performance in a regulated environment. The role operates in an Agile development environment and partners closely with R&D, Quality, Regulatory, Operations, and business teams.

• Writing software requirements to assess and mitigate product risk.
• Performing product risk management activities, including risk analysis, documentation, and mitigation related to product productivity and performance.
• Working with cross-functional teams to gather requirements, evaluate tradeoffs, and align technical solutions with business and customer needs.
• Applying systems engineering principles across the software lifecycle, including requirements engineering, software integration and testing, tradeoff analysis, configuration management, and verification/validation.
• Supporting quality and design documentation in compliance with FDA, ISO, and other applicable regulatory standards.
• Managing requirements, defects, and traceability in an Agile environment using Azure Dev Ops, Jira, Codebeamer, and Retina.
• Analyzing complex technical issues and presenting clear recommendations to stakeholders.
• Staying informed on emerging technologies and the IVD competitive landscape to support product differentiation and innovation.

• Bachelors degree in Engineering, Biomedical Sciences, or a related technical field with 4+ years of experience, or Masters degree with 2+ years, or PhD with 0 years.
• Demonstrated systems engineering expertise in software integration and testing, requirements engineering, tradeoff analysis, configuration management, and verification/validation.
• Experience writing software requirements to assess product risk.
• Experience in product risk management.
• Experience working with cross-functional teams to gather needs, evaluate tradeoffs, and implement solutions.
• Ability to work independently and collaboratively to solicit needs and perform tradeoff analyses.
• Experience working in a regulated environment (medical devices preferred; aerospace or other regulated manufacturing environments acceptable).
• Familiarity with FDA, ISO, and other relevant regulatory standards for diagnostic or medical device products.
• Interest in innovative technologies and understanding of the IVD competitive landscape.
• Experience producing and maintaining quality documentation.

• Experience in the regulated medical device or IVD industry.
• Knowledge of software reliability, usability, and manufacturability.
• Strong organizational and communication skills.