Fresenius Kabi USA

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

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

Full-stack Engineer

• 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

Engineer

• 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.

Senior Manager, Learning & Development – Clinical

Analyst

• Oversight and main contact for the administration of the Company’s purchase card, travel card and e-payables card payment program.
• Assist with daily cash management and the liquidity functions including cash pooling.
• Assist with the monthly Treasury closing activities.
• Monitor Treasury email inbox and address or assign issues.
• Process MDG-S (Master Data Governance-Suppliers) requests.
• Manage bank account and online banking administration including quarterly reviews and audit reporting.
• Assist with providing hedge accounting entries and documentation for Region North America (NAM) Operations.
• Provide backup and review for all daily, weekly and monthly cash activities for all NAM entities including wire processing, intercompany payments and monitoring of in-house cash accounts.
• Maintain and update interest rate justification and backup documentation.
• Assist with maintaining and developing Treasury metrics and KPIs.
• Support M&A activity related to treasury functions, including modeling and Treasury Integration.

Senior Treasury Analyst

General Counsel

• Provides commercial transactional and healthcare regulatory legal counsel in support of the US Pharma, Biopharma, Nutrition, and IV Therapy commercial operations
• Draft, review, and revise product purchase, supply, manufacturing, distribution, capital expenditure, research & development agreements
• Negotiate and resolve informal disputes with key suppliers and service providers
• Advise the Company on structuring business practices in compliance with applicable laws and regulations
• Provide direction to paralegals and legal administrative staff

Corporate Counsel

• Serve as the Medical reviewer at the Medical-Legal-Regulatory (MLR) review team for the US Clinical Nutrition team.
• Lead the management and oversight of Medical Information and medical affairs including new product launches for Clinical Nutrition team.
• Collaborate with the other medical affairs team members to provide expertise and support on a broad range of activities including medical communication, medical training, congress strategy and execution, and data generation and clinical education across Clinical Nutrition portfolio.
• Develop, maintain, and update standard response letters (SRLs), FAQs, and other medical information resources to ensure consistency and compliance with regulatory requirements.
• Collaborate with cross-functional teams to review product labeling, ensuring alignment with scientific evidence, regulatory standards, and therapeutic needs.
• Provide medical expertise to commercial, regulatory, and clinical teams for the launch and life-cycle management of clinical nutrition products.
• Prepare medical content for presentations, educational materials, and advisory boards as needed.
• Provide operational support to the US Clinical Nutrition Medical Affairs team including managing team projects, timelines, and budget, contracting, and vendor management.
• Collaborate with the Global Medical, Clinical, and Regulatory Affairs in the management of US-based clinical trials including regulatory requests and PMRs.

Manager, Medical Affairs – Clinical Nutrition

Therapist

• Primary lead for administering GPO contracting activities and acts as a liaison for related activities between Sales and Contract Marketing
• Leads GPO and IDN contract sign up process for all products and designated accounts under the commercial area of focus (Pharmaceuticals, Infusion Therapy & Medical Device, or Biosimilars)
• Administers, and maintains all contract set up in Model N system
• Working knowledge of the administration and governance of pricing relationships, membership rosters, and contract eligibility process
• Participates and recommends contract terms for customer agreements
• May directly interface with customer on contract negotiations
• Timely, and efficient confirmation, and validation of contract set up and eligibility within required timelines
• Compiles and maintains product information for bids/RFP’s and RFI’s
• Maintains and provides guidance on all contracting activities, such as bids/RFP’s, terms and conditions, and redlining in collaboration with other functional stakeholders in accordance with department and company policies
• Supports and executes contract strategy and bid responses in cooperation with senior leaders across the commercial organization
• Collaborates with internal functional groups relative to assigned accounts which includes written correspondence, contract updates and maintenance, milestone tracking, billing, and membership
• Proactively tracks, governs, and leads expiring contracts or extension activities
• Provides and ensures accuracy of ad hoc reporting as needed
• Identifies process improvement opportunities, and develops, or enhance tools to assist in the work deliverables
• Uses SAP, Model N, Qlik, CLM, CRM and other databases/tools to obtain, prepare, compile, and analyze information
• Analyzes KPIs to drive improvements in contract marketing process
• Provides support during new product launches by ensuring contract information is up to date
• Completes all training requirements, including all department-specific, compliance training, etc.
• Participates in any and all reasonable work activities as assigned by management
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Senior Analyst, Contract Marketing – Pricing, IV Therapy

• Technical project lead to plan and implemented design changes from R&D into manufacturing for their assigned product families.
• Utilize engineering principles, technical analysis, and problem-solving tools to resolve field and manufacturing product quality issues.
• Act as a primary technical liaison for purchasing, quality, manufacturing, and operations for product/part related issues.
• Networks with senior internal and external personnel in areas of expertise.
• Work across organizational boundaries, with field service engineers, marketing, R&D, quality teams and product managers to resolve quality, obsolescence, and manufacturability issues.
• Routinely provides advice and assists team members regarding unique problems.
• Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
• Mentors, coaches, and assign tasks to other team members assigned to their product families.
• Performs other related duties as assigned.

Principal Engineer – Product Sustaining

Operations

• Lead all daily contract operations including Capital and Software contracting
• Own day-to-day contract operations for Capital Equipment and service plans
• Manage bids/RFIs/RFPs in collaboration with Commercial teams
• Support Senior Management with departmental strategies and SOP development
• Act as a primary liaison across cross-functional teams for contract execution
• Prepare for internal/external quality and supplier audits
• Ensure setup and maintenance of customer-specific pricing in ERP systems
• Develop recurring operational reports and KPI’s
• Drive continuous improvement of Contract Marketing processes