Fresenius Kabi USA

Full-stack Engineer

• Design and develop components and subassemblies used in durable and consumable equipment designed by Ivenix / Fresenius Kabi
• Design and develop processes, tools, or fixtures for assembling and testing products
• Build and test prototypes to verify design function
• Establish and perform DoE to assess and characterize new solutions and designs
• Generate GD&T drawings identifying critical dimensions according to tolerance stack up analysis and manufacturing process capabilities
• Perform dFMEA according to product / system functional analysis, and update designs (3D and 2D) and solutions accordingly
• Investigate new technologies and best practices
• Optimize designs for low-cost, high quality, high reliability, and high-volume assembly
• Packaging of subsystems to meet industrial design goals
• Design complex electro-mechanical mechanisms to achieve engineering performance goals
• Establish engineering design documentation
• Prepare technical records and files, including engineering changes
• Focus design efforts on improved performance and reduced complexity
• Create artifacts in support of design, redesign, prototype, and transfer to manufacturing activities
• Perform and documents failure analysis of returned product
• Work with customers and vendors as needed regarding technical issues

Principal Engineer, Mechanical

Therapist

• Serve as the primary corporate accounts representative and executive point of contact for assigned national accounts across Group Purchasing Organizations (GPOs), distributors, Integrated Delivery Networks (IDNs), home healthcare groups, retail organizations, managed care entities, physician groups, and other strategic partners.
• Develop and execute comprehensive strategic account plans that align Fresenius Kabi’s portfolio and commercial strategy with customer priorities to drive long-term growth and partnership.
• Establish and maintain trusted relationships with executive leadership and key decision makers, including C-suite stakeholders and key opinion leaders within customer organizations.
• Lead the joint business planning process with strategic customers to define shared goals, identify growth opportunities, and ensure alignment on strategic initiatives.
• Drive revenue growth and market expansion across assigned accounts by identifying opportunities for portfolio adoption, contract optimization, and new business development.

Director, Corporate Accounts – IV Therapy

Procurement

• Assist in the development and own the regional execution of global category strategies, ensuring alignment with Global sourcing roadmaps Preferred supplier and partner models
• Adapt global strategies to the Americas context while preserving strategic intent and governance discipline
• Serve as the primary interface between Global Indirect Procurement and Americas stakeholders, ensuring continuous collaboration and alignment improvement
• Translate global strategy into annual sourcing plans and sustainable pipeline management
• Lead / Co-lead complex sourcing initiatives delivering execution of end-to-end sourcing processes, from demand intake and market analysis through contract award and implementation
• Negotiate commercial, contractual, and service-level agreements to deliver measurable value (cost, quality, speed, innovation)
• Deploy globally defined strategic supplier ecosystem consistently across the Americas
• Drive supplier performance management, QBRs, and continuous improvement initiatives
• Identify opportunities for supplier consolidation, innovation partnerships, and risk mitigation
• Act as a trusted business partner to R&D, Clinical Operations, Medical Affairs, Corporate Finance, Commercial, HR, and regional business stakeholders

Category Manager – Purchasing, R&D, Professional Services

Project Manager

• Provide strong leadership for TPM commercialized products to ensure finished drug products are in compliance with current GMP and regulatory requirements.
• Work closely with Third Party Manufacturing Organizations and/or Suppliers to successfully manufacture and release commercial and validation/launch batches.
• Evaluate, review and approve external change controls for TPM.
• Review TPM product validations to meet minimum compliance requirements for FK ANDA or when applicable.
• Review and approve methods, specifications, and artwork for TPM products.
• Create and maintain Technical Documents for all products at each CMO.
• Lead continuous improvement initiatives to update Standard Operating Procedures (SOPs).
• Collaborate with CMOs and Regulatory on evaluating product shelf-life extension.
• Lead TPM technical assessments and ad hoc project management (including Transportation studies, improve current processes, etc.)
• Manages internal and external resources to complete projects related to TPM and to meet current GMP and regulatory requirements.
• Act as a technical liaison between CMOs and internal FK teams to complete projects, come to resolutions, and support TPM product releases.
• Support Product Launches, business integration/acquisition activities based on business needs.

Project Manager – Technical

Compliance

• Track and validate customer performance against contractual commitments, including tiered volume commitments, rebates and agreed upon contractual terms.
• Oversee the administration and fulfillment of contractual obligations and commitments.
• Extract, analyze and interpret data from CRM systems to identify compliance gaps and trends.
• Prepare monthly dashboards and ad hoc reports for leadership.
• Develop and maintain documentation related to contract performance.
• Support customer obligation inquiries and disputes related to contractual obligations.
• Support commercial teams in structuring contracts that drive long-term customer relationships.
• Maintain detailed records of customer commitments, amendments, and compliance reports.
• Work with legal and compliance teams to assess risks and implement corrective actions.
• Provide insights and recommendations to senior leadership on contract performance.
• Prepare documentation to support Review Committee requirements.
• This individual will interface regularly with Marketing, Pricing, Legal, Finance, and other functional areas to ensure that key information is incorporated in the decision-making process.
• Directly interface with customers on contract obligation reporting and measurement.
• Identify process improvement opportunities and develop tools to assist in the project deliverables.
• Lead project to organize project to report and socialize business metrics and key performance indicators (KPIs).
• Contribute to the preparation of ad-hoc presentations, assess the impact of the analysis, and make appropriate recommendations to Senior Management.
• This role does not have any direct reports but will need to work in a matrix management environment to manage project deadlines and provide frequent updates to key stakeholders on deliverables.

Senior Analyst, Contract Marketing – Contract Compliance

Customer Success Manager

• Lead Commercial Enablement Strategy (CRM & Customer Engagement)
• Serve as Regional Salesforce Product Owner
• Own CRM Demand Governance & Prioritization
• Champion User Experience, Adoption & Data Integrity
• Deliver Strategic Commercial Insights
• Lead Change Management & Capability Development
• Drive Automation & Scalable Process Architecture
• Oversee Configuration Governance & Release Execution
• Partner Cross-Functionally with IT & Global Stakeholders
• Evaluate & Scale Emerging Capabilities

Manager, CRM System Operations

System Administrator

• Responsible for all R&D computer systems in the Laboratory
• Administration of all informatics systems including Empower CDS, RAM, isolated networks for standalone computerized systems
• Troubleshoots and supports Empower CDS, Regulatory Asset Manager (RAM), isolated networks, and other systems
• Supports account management, data management, and maintains robust database systems
• Assists Technical Team Lead with global Enterprise IT initiatives
• Issues licensing of all software packages within R&D laboratories
• Maintains software related Service Contracts
• Coordinates with vendors for system maintenance and updates
• Maintains inventory of all computer hardware, software and licenses
• Responsible for disaster recovery of all R&D software systems
• Provides qualification and change control support associated with computerized system installation
• Maintains expertise through ongoing training and participating in industry associations
• Develops relationships with critical stakeholders to implement solutions

Systems Administrator

• Performs Mechanical Engineering tasks for the life-cycle management for on-market products manufactured at the production unit of active and non-active hardware medical devices, software, and laboratory equipment.
• This includes maintaining design requirements, design specifications, and risk management documentation; performing mechanical testing; supporting verification and validation activities.
• This also includes performing technical and problem-solving activities, in collaboration with Quality Assurance, to analyze and resolve field and manufacturing product issues.
• Supports / leads 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.
• Independently define and analyze material specifications, components, and process techniques to ensure proper functionality and long-term performance.
• Develop and execute protocols for evaluating existing mechanical designs.
• Networks with senior internal and external personnel in areas of expertise.
• Routinely provides advice and assists team members regarding unique problems.
• Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
• Performs other related duties as assigned.

Principal Engineer – Mechanical

Financial Planning and Analysis

• Lead in preparation of Annual Budget, Long Range Plan, and quarterly Forecasts for cost centers and revenue
• Prepare, analyze, report, and reconcile monthly actual results compared to budget, forecasts, and prior year for North America
• Execute analytics projects using Python, Power Query, R, or SQL to prepare and/or merge internal data assets and perform advanced analysis
• Collect and analyze business functions and product lines’ monthly and/or weekly Sales reports and ensure for accuracy
• Contribute to multiple internal data initiatives, including but not limited to new tool development, automation, simulation, data integration and visualization dashboards
• Manage the relationship with department managers and communicating financial results
• Assist in reviewing costs and performing cost/benefit analyses related to proposed projects/programs in order to improve operational and financial effectiveness of the company
• Prepare and analyze financial actuals, budget, forecasts, and variance reports on a monthly, quarterly, and annual basis
• Develop reports for forecasting/trending and results analysis
• Standardize reporting using Power BI, implementing new technical capabilities
• Assist with month-end close activities and reporting
• Responsible for loading and maintaining portions of P20, TM1, BCS, and FKGAN for actual results, as well as quarterly forecasts and annual budgets
• Assist with coaching of Financial Development Program Associate
• Lead efforts on ad hoc and special projects within finance team

Senior Financial Analyst

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

• 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

• 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.