Principal Data Systems Engineer — Healthcare Tech

Fresenius Kabi; Lake Zurich (IL); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation and holidays

Health benefits (medical, dental, vis2

Life insurance

Job summary

Fresenius Kabi USA is seeking a Principal Engineer to provide technical leadership for data management software across the product lifecycle. You will define and manage system requirements and designs, collaborating with engineering, product management, quality, regulatory affairs and customer support to deliver reliable, compliant solutions.

Responsibilities include architectural design for data management, device integrations, and interfaces; translating regulatory needs into verifiable

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related technical discipline with 5+ years related experience.
• Demonstrated expertise in developing system requirements and designs for complex software solutions involving data acquisition, device configuration, device control, and system-to-system interfaces.
• Proven ability to translate marketing and regulatory requirements into system design and requirements.
• Experience designing software within a regulated or quality-controlled environment, preferably healthcare or medical devices.
• Proven experience defining architecture, system behavior, and technical direction for enterprise-class Windows-based and web-based applications.
• Strong experience with relational database design, preferably Microsoft SQL Server, as well as APIs, web services, and system integration.
• Demonstrated technical leadership within Agile software development environments.
• Strong working knowledge of enterprise networking and security concepts, including DNS, authentication and authorization, firewall configuration, and secure communications using certificate-based security.
• Knowledge of secure software development and cybersecurity practices, including identifying and mitigating security risks.
• Strong analytic and problem-solving skills, with the ability to evaluate technical issues and recommend resolutions.
• Excellent written and verbal communication skills, the ability to explain technical concepts, risks, recommendations, and tradeoffs to technical and non-technical stakeholders.
• Proven experience leading technically across geographically distributed and offshore development teams.

Responsibilities

• Contributes to system architecture designs for data management software, device integrations, databases, networks, and external interfaces.
• Defines and maintains clear, verifiable system requirements and traceability based on approved product, user, regulatory, quality, risk, and cybersecurity needs.
• Uses Jira and other approved tools to decompose approved requirements into implementable work items, define acceptance criteria, track requirement-related anomalies and decisions, and maintain alignment between planned scope and the controlled requirements baseline.
• Provides technical input for user manuals and other technical documentation to ensure product functionality, configuration, compatibility, limitations, warnings, interfaces, and release-specific changes are accurately described.
• Provides technical leadership for assigned product features throughout the complete development lifecycle, from concept and requirements, through implementation, verification, release, and post-release support.
• Supports root-cause analysis and helps identify corrective actions or design changes.
• Defines system architecture, design direction, and implementation expectations for distributed and offshore development teams.

Skills

System requirements

Data management

Regulatory compliance

Agile software

Windows/web apps

SQL Server

APIs/web services

Security concepts

Distributed/offshore teams

Technical leadership

Education

Bachelor’s degree in Software Engineering/CS/CE or related

Tools

Jira

Job description

Fresenius Kabi USA is seeking a Principal Engineer to provide technical leadership for data management software across the product lifecycle. You will define and manage system requirements and designs, collaborating with engineering, product management, quality, regulatory affairs and customer support to deliver reliable, compliant solutions.

Responsibilities include architectural design for data management, device integrations, and interfaces; translating regulatory needs into verifiable