Fresenius Kabi USA

Marketing

• Creates and manages customer agreements for GPO, IDN’s and complex key accounts
• Works cross-functionally with the Commercial, Finance, and Legal teams on contract development, administration, compliance and reporting
• Develops implements, administers, and maintains the key contracts under area of responsibility including contract eligibility and contract pricing
• Develops and coordinates assigned account contracts, amendments, new product offers, contract implementation and maintenance including contract eligibility and COT review
• Manages pricing relationships between GPO contracts including Acute, Alternate, DSH, Retail and Committed contracts
• Works with Sales and National Accounts team to support and execute pharmaceutical support of contract strategies
• Redlines customer agreements in collaboration with internal team stakeholders (legal, contract marketing and NA)
• Responsible for leading RFI, RFP and bid submissions
• Generates monthly customer and sales reports with an emphasis on continual enhancements
• Conducts analysis to calculate customer rebates and penalties as outlined in customer agreements
• Manage and resolve customer pricing disputes
• Prepares and distributes ad hoc sales and management reports
• Responsible for the developing and maintaining content for the Contracts and Pricing Team Training Library and SOP’s
• Coordinates and provides training to new hires and cross functional partners
• Identifies and implements new processes to improve overall team efficiency and productivity
• Facilitates and supports cross-functional process improvements
• Facilitates and supports the implementation of process improvements in Contract Marketing
• Completes all training requirements, including all department-specific, compliance training, etc.
• Participates in any and all reasonable work activities as assigned by management.

Analyst, Contract Marketing – Pharma

Full-stack Engineer

• The Senior Engineer leads the definition of the electrical architecture of Infusion devices developed by Fresenius Kabi.
• Leads the design and development of products and/or processes relating to the electrical architecture.
• Designs analog,
• digital,
• mixed signal and power circuits.
• Investigates new technologies and best practices.
• Ability to troubleshoot equipment problems and perform complex system tests.
• Participate in all phases of the product lifecycle,
• including development,
• verification,
• new product introduction,
• and post market support.
• Generates and implements innovative solutions to complex problems through the use of multiple disciplines and technical principles.
• Advises senior management regarding appropriate action.
• Establish best practices for engineering documentation within the electrical team.
• Evaluates results relative to product requirements,
• definitions and/or program goals.
• Applies standard techniques to solving difficult problems.
• Displays advance understanding of 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 along with appropriate regression tests to resolve difficult problems,
• from conception to final design with team input.
• Assesses risks and creates test plans around risk priorities;
• analyzes results,
• states conclusions,
• and assesses residual risks after tests are complete;
• in addition,
• assesses adequacy of support for conclusions by test results.
• Displays full understanding and knowledge of regulations,
• to apply guidance and standards on design verification and design validation to test activities and work products;
• prepares documentation for compliance with standard operating procedures.
• Networks with senior internal and external personnel in own area of expertise to effectively operate and facilitate cross-functional teams.
• Routinely provide advice and assistance to team members regarding routine and unique problems.
• May supervise or direct lower-level engineers on assigned projects.

Senior Engineer, Electrical

QA Engineer

• responsible for scheduling and leading domestic and international quality audits
• Identifies top compliance risks and communicates to Fresenius Kabi Management
• lead internal audits of Fresenius Kabi facilities based on the FDA’s System Based Inspection Policy and GMP
• develop audit plans, conduct quality audits, prepare audit reports, and communicate findings
• Lead / participate in Global / Divisional internal audits of Fresenius Kabi facilities
• review and evaluate internal audit response against Fresenius Kabi’s policies and procedures requirements
• drive closure of corrective and preventive actions
• follow up on prior audit recommendations to ensure implementation and compliance
• assist in maintenance of the annual external audit schedules
• lead and / or assist with the development of compliance and quality training
• revise, review, and write SOPs, checklists, and quality documents

Quality Assurance Manager

Engineer

• Plans, designs, executes, documents, and analyzes a regimen of tests to predict the reliability of new products and product changes
• Operates within defined processes and procedures consistent with a regulated environment
• Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors
• Effectively operates as an individual contributor and a member of the large team
• Exercises judgment within defined procedures and practices to determine appropriate action
• Participates in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects
• Maintains reliability test equipment including the execution of regular maintenance activities
• Accurate recording of test results and defects in Excel, Jira, or other test databases
• Assists in root cause analysis of Field Returns and Reliability Test failures
• Develops and maintains detailed troubleshooting documentation, for both internal and external customers
• Assists in documentation, tracking, and analysis of field failure data
• Develops and executes written test protocols designed to evaluate and demonstrate product reliability including but not limited to QALT (Quantitative Accelerated Life Testing) and Reliability Life Testing
• Develops, fabricates, and qualifies reliability test fixtures
• Design in collaboration to the Hardware and Sustaining teams and develop processes, tools or fixtures for testing products
• Organizes test records to ensure that records are indexed, archived, and can be retrieved
• Evaluates results relative to program goals
• Applies standard techniques to solving difficult problems
• Applies functional understanding of reliability theories and practices to daily activities
• Display full understanding and knowledge of regulations to apply guidance and standards on reliability activities and work products; prepare documentation for compliance with standard operating procedures
• 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 Engineer – Reliability

Project Manager

• lead and coordinate cross-functional projects to ensure delivery on time, within scope, and on budget
• apply project management methodologies
• define clear project goals, milestones, and timelines
• support design reviews, qualification activities, and technical decision-making
• oversee project budgets and ensure cost control
• monitor and report on project performance to stakeholders
• motivate and guide cross-functional teams
• encourage team self-reflection and learning

Project Manager, Engineering

Director

• Lead cross-functional planning and execution for new product launches from pre-approval through post-launch stabilization
• Partner with Marketing owners and Business Unit Launch Management to develop integrated launch plans aligned to regulatory milestones, manufacturing readiness, supply availability, and commercial priorities
• Identify launch risks and lead mitigation planning
• Own the commercial launch management framework, including standardized processes, tools, templates, timelines, and governance
• Develop and deliver launch management training for cross-functional stakeholders
• Collaborate closely with Marketing, Supply Chain and Manufacturing to align demand forecasts, allocation strategies, and launch sequencing

Director, Commercial Launch Management

• Leads the development and revision of all product risk documentation per current industry standards and regulatory requirements
• Collaborates with cross-functional team members to build Use and Design Failure Modes and Effects Analyses (FMEAs) and Risk Assessments
• Identifies, and verifies effectiveness of, risk control measures throughout the product lifecycle
• Reviews Process FMEAs developed by contract and internal manufacturing teams
• Investigate issues to determine root cause using established problem-solving tools
• Leads Risk Management Committee meetings as appropriate, preparing information to be presented and capturing and tracking action items to closure
• Drives compliance with internal risk processes and creates or refines tools and templates to ensure compliance per ISO 14971 and other standards and regulations
• Develops and updates the Safety Assurance Case in collaboration with Clinical Product Specialist, Human Factors Engineering and Regulatory Affairs
• Contributes to other R&D system engineering activities as needed including requirements management, architecture review, V&V strategy, and post-market surveillance
• Provides training as needed when significant changes are made to risk processes
• Participates in design activities to ensure risk reduction is considered in product design decisions
• Contributes to risk strategies for new product feature development
• Participates in Usability Engineering activities
• Works independently with latitude for individual judgment

Senior Principal Engineer – Systems-Risk

Field Engineer

• Provide technical direction and support to customers
• Serve as customer contact on technical and service-related problems
• Demonstrate uses and advantages of products
• Install, check out, operate, maintain, repair, and upgrade equipment
• Provide guidance and training to customer personnel
• Analyze equipment failures and recommend corrective action
• Maintain customer good will through effective communication