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Principal Engineer (Software)

Fresenius Kabi USA

Lake Zurich, ILOnsitePosted 2 days ago$105,000 - $115,000/year
Full TimeSenior LevelTech & Data (Health IT)Pharmaceutical
Original posting ↗

Summary

The Principal Engineer works under minimal supervision while providing technical leadership for systems and software development activities of data management software throughout the product lifecycle. Apply standard engineering practices to resolve difficult problems, from conception to final design with team input. Defines and manages requirements and system designs under the guidance of technical leads. The position collaborates with Engineering, Product Management, Quality, Regulatory Affairs, and Customer support teams to help deliver reliable, compliant, and customer-focused solutions.

Job description

Job Summary

The Principal Engineer works under minimal supervision while providing technical leadership for systems and software development activities of data management software throughout the product lifecycle. Apply standard engineering practices to resolve difficult problems, from conception to final design with team input. Defines and manages requirements and system designs under the guidance of technical leads. The position collaborates with Engineering, Product Management, Quality, Regulatory Affairs, and Customer support teams to help deliver reliable, compliant, and customer-focused solutions.

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.

Requirements

  • 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.
  • The successful candidate must be able to effectively speak, read, write, and understand English.

Requirements

  • Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related technical discipline
  • 5+ years related experience
  • Expertise developing system requirements and designs for complex software solutions involving data acquisition, device configuration, device control, and system-to-system interfaces
  • 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
  • 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
  • Experience with APIs, web services, and system integration
  • Demonstrated technical leadership within Agile software development environments
  • Knowledge of enterprise networking and security concepts including DNS, authentication and authorization, firewall configuration, and certificate-based security
  • Knowledge of secure software development and cybersecurity practices
  • Strong analytic and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience leading technically across geographically distributed and offshore development teams
  • Must be able to effectively speak, read, write, and understand English
  • Must be authorized to work for any employer in the United States

Benefits

  • 401(k) With Company Contributions
  • Paid Vacation
  • Paid Holidays
  • Personal Days
  • Employee Assistance Program
  • Medical, Dental & Vision
  • Prescription Drug Coverage
  • Life Insurance
  • Disability Insurance
  • Wellness Program
  • Bonus Plan

Company overview

Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.

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