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.

Salary Range: $105,000 - $115,000 based on experience

• Position is eligible to participate in a bonus plan with a target of 8% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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.

This job position within the Business Unit – Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

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 Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.