Fresenius Kabi USA

Engineer

• Define and execute test cases for new and existing Ivenix Infusion System products.
• Follow pre-established testing procedures.
• Accurately assess results for validity and conformance to specifications.
• Develop and maintain detailed documentation for both internal and external customers.
• Trace test activities and results to system and subsystem requirements, escalating findings through the defined workflows.
• Operate within defined processes and procedures consistent with a regulated environment.
• Work on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
• Effectively operate as an individual contributor and a member of the large team.
• Set up and maintain test articles and test fixtures.
• Apply sound judgment to resolve routine and non-routine issues, follow established guidelines, and escalate when situations fall outside defined parameters.
• Participate in technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.

Senior Engineer, Software Test

• Set up and maintain test articles and test fixtures.
• Execute test protocols using Test Management Software
• Execute Problem Resolution Procedure in JIRA
• Perform and review verification tracing

Software Test Engineer

• Perform standard Mechanical Engineering tasks within a sustaining engineering role function, specifically in a manufacturing environment.
• Select appropriate techniques to solve problems and make design recommendations under direction of supervisor.
• Assess results for application, validity and conformance to specifications.
• Utilize engineering tools to solve technical problems e.g., CAD design, FMEA, Finite Element Analysis, Process Modeling, Design of Experiments.
• Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
• Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.

Senior Engineer

Full-stack Engineer

• Performs Mechanical Engineering tasks for life-cycle management for on-market products
• Maintain design requirements, design specifications, and risk management documentation
• Perform mechanical testing and support verification and validation activities
• Perform technical and problem-solving activities in collaboration with Quality Assurance
• Support/lead the creation of hardware requirements and designs specifications, including 3D modeling, FEA, FMEA, tolerance analysis, and drawing creations
• Utilize engineering principles, technical analysis, and problem-solving tools to resolve field and manufacturing product quality issues
• Develop and execute protocols for evaluating existing mechanical designs

Principal Engineer

Accounting Manager

• Oversee recurring revenue recognition and monthly/quarterly close activities, ensuring compliance with IFRS 15 and internal policy, present results in Management Review.
• Manage preparation, review, and posting of Gross-to-Net (GTN) journal entries, accruals, and reserve reconciliations.
• Evaluate customer contracts for revenue implications and determine appropriate accounting treatment in accordance with established guidance.
• Maintain end-to-end understanding of revenue processes, systems, and data flows to ensure accuracy and integrity, under direction of leadership.
• Partner cross-functionally with Commercial, Sales, Contracts, Customer Financial Services, and Legal to assess contract structure, pricing, and revenue impacts.
• Collaborate with IT and Finance Systems to resolve system issues, validate data accuracy, and implement process enhancements.
• Identify and implement process improvements to strengthen efficiency, accuracy, and GTN methodologies.
• Lead or support system implementations and upgrades affecting revenue processes.
• Manage internal and external audit activities related to revenue and GTN reserves.
• Partner with Internal Controls to evaluate and strengthen controls across the revenue lifecycle, ensuring compliance and risk mitigation.
• Provide coaching, training, and performance feedback to Senior Accountants.

Manager, Accounting – Revenue

Software Engineer

• Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations
• Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects
• Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software and product development life cycle
• Assist with cross-functional risk assessments and contribute to the creation of risk management plans related to software and product quality
• Review and assure that verification test plans, test cases, and validation protocols are complete and provide meaningful results to confirm design outputs meet design inputs
• Stay updated on industry trends, regulatory changes, and best practices in medical device software and product quality
• Participate in audits and inspections to ensure compliance with relevant quality standards and regulations
• Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective and preventive actions (CAPAs)
• Facilitate communication between development teams and regulatory affairs to address quality-related issues
• Contribute to continuous improvement initiatives by leading complaint investigations, CAPAs, and other corrective actions
• Review design specifications for clarity, testability, and regulatory compliance
• Participate in design reviews for new products and establish quality plans
• Facilitate pre- and post-market risk management activities
• Maintain accurate records to assure regulatory compliance throughout the product lifecycle
• Provide quality oversight for software deliverables, ensuring compliance with software lifecycle requirements
• Strengthen and maintain the QMS structure for design and software quality by defining workflows, templates, and governance for document control

Engineering Specialist, Quality

• Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations, including: IEC/ISO 62304: Medical Device Software Lifecycle, 21 CFR 820.30: Design Controls, ISO 14971: Medical Device Risk Management, IEC 60601: Medical Device Electrical Safety, ISO 10993: Biological Evaluation of Medical Devices, IEC 62366-1: Application of Usability Engineering to Medical Devices
• Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects.
• Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software and product development life cycle.
• Assist with cross-functional risk assessments and contribute to the creation of risk management plans related to software and product quality.
• Review and assure that verification test plans, test cases, and validation protocols are complete and provide meaningful results to confirm design outputs meet design inputs.
• Stay updated on industry trends, regulatory changes, and best practices in medical device software and product quality.
• Participate in audits and inspections to ensure compliance with relevant quality standards and regulations.
• Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective and preventive actions (CAPAs).
• Facilitate communication between development teams and regulatory affairs to address quality-related issues.
• Contribute to continuous improvement initiatives by leading complaint investigations, CAPAs, and other corrective actions.
• Review design specifications for clarity, testability, and regulatory compliance.
• Participate in design reviews for new products and establish quality plans.
• Facilitate pre- and post-market risk management activities.
• Maintain accurate records to assure regulatory compliance throughout the product lifecycle.

Senior Engineer, Quality

Manager

• Serve as the primary strategic interface between Commercial business teams and IT resources
• Partner with IT capability owners and solution architects
• Represent the “voice of the customer” in proposed solutions
• Contribute to business case development
• Partner closely with IT delivery teams to ensure smooth execution of initiatives
• Establish and track program KPIs and outcomes

Senior Manager, IT Business Relationships

• Lead all activities relative to pharmacovigilance activities with Fresenius Kabi USA biosimilar business partners, both locally and globally.
• Establish relationships, and safety and data exchange agreements (SDEA) with business partners and HUB services, serving as the primary liaison ensuring they meet all global and local regulations, policies, and procedures.
• Drive new initiatives, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
• Responsible for ensuring the execution and implementation of SDEA, directly supports, and provides oversight of all data exchange and reconciliation activities.
• Responsible for oversight of Risk Evaluation and Mitigation Strategy program for biosimilars ensuring execution of program requirements collaborating with vendor and cross functional teams.
• Responsible for writing and/or review of applicable Standard Operating Procedures (SOPs).
• Identifies new procedures needed and changes to be made to established procedures to implement programs.
• Ensure that all global and local procedures are in alignment.
• Train and mentor staff regarding all established procedures and agreements.
• Work cross-functionally within the Global Vigilance team, supporting all PSP Vigilance activities, as needed.
• Review and approve adverse event information entered into the global complaint management workflow (gCMW).
• Responsible for managing and facilitating the preparation, review, and submission of expedited, as well as non-expedited case reports in accordance with SOPs, as well as domestic and foreign regulatory requirements.
• Serve as an Adverse Drug Event (ADE), PV expert, and MedDRA coding expert.

Senior Manager, Patient Support Program – Vigilance

• Guides the conceptualization of new methodologies while identifying improvements for processes and best practices in software testing.
• Generates innovative test solutions to complex problems using multiple disciplines and technical principles.
• Measures test effectiveness, including defect trends and automation performance, and advises senior management on quality risks and recommended actions.
• Analyzes, plans, designs, executes, and documents tests of highly complex software applications and/or processes within established medical product design controls.
• Plans and performs unit testing (including C# unit tests), integration, system, and regression testing for new features, enhancements, and defect fixes across multiple software subsystems.
• Designs and develops automated tests using reusable and scalable components to support repeatable testing and CI/CD pipelines.
• Perform exploratory and ad-hoc testing to identify defects, edge cases, boundary conditions, and failure modes not covered by scripted or automated tests.
• Works with senior leadership to improve software engineering process efficiency.
• Works with internal and external staff to identify test coverage needs, high-risk areas, and negative scenarios, and to improve overall software testability, robustness, and other software engineering activities.
• Investigates and documents software defects, working across services, interfaces, data layers (including SQL-based systems), and environments.
• Mentors and guides junior staff, routinely provides technical input on architecture and design decisions to improve observability, testability and diagnosability, while remaining a hands-on individual contributor within the development team.
• Develops and maintains technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Senior Principal Engineer – Software HIT Test

DevOps Engineer

• Plans, designs, implements and maintains Continuous Integration/ Continuous Delivery (CI/CD) functions and other DevOps functions that enhance R&D product/service delivery capabilities.
• Administers and maintains physical and virtual Windows and/or Linux based systems that support product/service delivery teams.
• Implements and maintains internal R&D engineering networking, hardware and software infrastructure to support engineering and test efforts.
• Performs engineering tasks adhering to requirements, definitions and/or program goals, and applies standard techniques to resolve moderate to high complexity problems/defects.
• Displays a solid understanding and ability to apply technical theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions, and performance.
• Wide latitude for independent judgment to resolve issues and contribute to the team’s development.
• Works with senior leadership to improve software engineering process efficiency.
• Assists with Project timing, tracking progress to program schedule.
• Recognizes and Identifies automation improvements for software engineering process deficiencies and software development best practices.
• Mentors and guides junior staff, routinely provides advice and assistance to team members regarding routine and unique problems.
• Collaborates with internal and external staff to perform software engineering activities.
• Investigates, recommends and implements new technologies, processes and best practices to enhance R&D capabilities.
• Understands regulations, develops and maintains technical records and detailed documentation for internal and external stakeholders, that follow compliance with standard operating procedures and good documentation practices.
• Collaborates with corporate Enterprise IT and R&D local IT as needed to support DevOps and R&D Engineering infrastructure, and to enable personnel to perform successfully.
• Develops and validates tools and automation software used in the development, verification and/or validation of Fresenius-Kabi products/services.
• Collaborates with software development team on the resolution of cybersecurity vulnerabilities.

Principal Engineer – DevOps

• Analyzes, plans, designs, executes, and documents software applications and/or processes within established medical product design controls.
• Designs and develops software adhering to product requirements, definitions and/or program goals.
• Applies standard techniques and resolves moderate to high complexity problems/defects, performing root cause and failure analysis.
• Displays a solid understanding and ability to apply technical theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identifies coverage of risks, requirements, architectural components, functions, and performance.
• Wide latitude for independent judgment to resolve issues and contribute to the team’s development.
• Works with senior leadership to improve software engineering process efficiency.
• Performs code reviews to confirm software implemented to approved designs, specifications and meet quality standards.
• Assists with Project timing, tracking progress to program schedule.
• Recognizes and Identify improvements for software engineering process deficiencies and software development best practices.
• Mentors and guides junior staff, routinely provides advice and assistance to team members regarding routine and unique problems.
• Works with internal and external staff to conduct design, redesign, prototype, and other software engineering activities.
• Authors and reviews software specifications compliant with design control process.
• Develops and maintains technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Senior Engineer, Software HIT

• Develops system- and subsystem-level requirements for medical devices that include electromechanical hardware, software, disposables, and labeling.
• Reviews systems engineering related processes and ensures they are current with industry standards and regulatory requirements.
• Contributes to other R&D system engineering activities as needed including risk management, architecture review, V&V strategy, and post-market surveillance.
• Keeps abreast of new developments in the industry and translates those developments into new and viable options for the organization and customers.
• Investigates issues to determine root cause using established problem-solving tools.
• Ensures that research and design methodologies meet established scientific and engineering standards.
• Participates in design activities to ensure overall system performance is considered in product design decisions.
• Presents technical information in a clear and precise manner.
• Works independently with latitude for individual judgment.
• Exercises judgment within defined procedures and practices to determine appropriate action.

Principal Engineer – Systems, Requirements

• Develop high-quality presentations supporting leadership communication and decision-making
• Proactively manage and monitor critical initiatives, projects, and tasks across Portfolio and R&D
• Provide hands-on support for daily business operations, including research and project coordination
• Deliver support for priority projects, ensuring measurable progress and alignment with leadership goals
• Serve as a central point of contact to promote effective collaboration across departments, regions, and teams
• Manage key analytics to generate insights and provide clear recommendations
• Lead the development of essential management reports
• Assist in the development and execution of the annual strategy plan for the Pharma business unit
• Organize and facilitate leadership team meetings, including setting agendas and tracking action items
• Attend local, national, and global meetings as needed

Manager – Strategy Execution

• Partner with Fresenius Kabi team members to consult on training approaches that support tactical training and clinical education.
• Design and develop L&D resources and programs.
• Apply clinical expertise to design training assets for Fresenius Kabi products.
• Manage design and development of training assets through the MRL process.
• Lead clinical and healthcare platform content development to create and deploy learning solutions.
• Develop learner assessments and measure proficiency.
• Provide remediation plans and conduct performance assessments.
• Serve as a subject matter expert for IV Therapy and support customer needs.