ICU Medical

Compliance

• Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
• With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
• Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.

Senior Associate, Regulatory Affairs

Sales

• Point of contact for assigned Sales Reps and Region Managers
• Primary sales contact for Alternate Site customer base
• Assist in the sales cycle from initial inquiry to close of business
• Maintain and enhance relationship with existing customer base in collaboration with Sales team
• Point of contact for inbound inquiries, providing prospect with product information, marketing materials and samples
• Work directly with authorized Distributor’s Inside Sales Departments to provide product solutions and price quotes
• Generate new sales opportunities from phone & email inquiries
• Provide technical support and maintain a strong level of product & competitor knowledge
• Direct communication with distributor, distributor reps and end users for maximum sales efficiency
• Manage ICU Website inquiries related to sales opportunities
• Assist Sales Reps with territory management (provide sales reports, research discrepancies, etc.)
• Coordinate the gathering and dissemination of sales forecast/pipeline data, wins/losses for IKAP database
• Generate and submit sales documentation for Sales Reps (Quotes, Relationship Forms, GPO lookup)
• Weekly reporting for high priority or high visibility items
• Manage vendor credentialing process with various credentialing companies
• Support & perform special projects for corporate accounts IDN’s
• Act as liaison for internal & external sales communication
• Work on special projects as assigned

Sales Support Representative

Procurement

• Develop and implement category strategies globally, including identifying needs, project planning, collecting internal and external data, performing strategic analysis and identifying opportunities, formulating procurement strategies and developing implementation plans.
• Form, lead, and facilitate cross-functional teams as applicable to execute the procurement process and plans; enable supplier selection and decision process; lead/facilitate contract development, negotiation and execution process, including complex commercial negotiations involving pricing, service levels, risk allocation, liability, and performance incentives.
• Manage strategy alignment, long term security of supply, supplier performance, and establish preferred supply base.
• Ensure optimal supplier pricing, supply responsiveness, quality, and contractual compliance.
• Own the end-to-end contract lifecycle, including negotiation, execution, amendments, renewals, compliance monitoring, and terminations.
• Partner with Legal to structure and negotiate contract terms and lead resolution of disputes, claims, and performance gaps.
• Establish and maintain master agreements, long-term supply agreements, and SOW frameworks that support scalability, risk mitigation, and operational efficiency.
• Develop appropriate risk management strategies which anticipate and address an extensive range of commercial, supply, and contractual risk scenarios to assure supply of ICU Medical’s requirements.
• Maintain industry intelligence on technology trends, sourcing options, and competitive pricing.
• Measure and report on commodity performance objectives, monitor supplier performance, conduct periodic business reviews, and initiate corrective action when necessary, including contract-based KPIs, SLAs, and scorecards.
• Review, negotiate, and maintain Supplier Agreements and supporting documentation.
• Benchmark prices and pricing information to ensure that the company is receiving the most cost-effective, highest quality products.
• Develop and maintain relationships with key stakeholders to support the sourcing process.
• Coordinate with other functions and impacted stakeholders to assure timely implementation and compliance with the agreed sourcing strategies.
• Work on special assignments as they arise.

Global Category Manager – Contracts and Purchased Finished Goods

Product Marketing

• Responsible for the development and execution of marketing strategy, including positioning, promotion, sales and marketing initiatives and launch planning to build awareness and generate demand of current and new products.
• Create a strategic plan that aligns with sales goals to drive business growth.
• Develop, execute and measure the key marketing initiatives, including campaign development and sales execution, to meet strategic business unit goals within budget, ensuring close attention to branding guidelines
• Maintain regional dashboards that provide clarity with execution of key initiatives, and supporting assumptions
• Serve as the primary product expert and function as a knowledge resource for customers, sales, R&D, product engineering, and service personnel.
• Consult on product design, development and release process road map
• Consult on requirements for current and future products by conducting market research, collecting and analyzing market data, trends, customer attitudes and behaviors as well as the competitive landscape.
• Coordinate the collection, description, analysis and prioritization of requests for new product functionality from customers, with a strong emphasis on teamwork, collaboration and communication.
• Support marketing, sales and clinical support teams through the development and maintenance of various technical marketing collateral including application notes, FAQs, product notes, user guides, field training presentations, online marketing content and demos.
• Develop hands-on, in-depth knowledge of competitive products and maintain technical analysis of competitive strengths and weaknesses, feature sets, underlying technology, product workflow, usability, etc. to establish technical differentiation and feature/benefit statements.
• Solicit customer, prospect and partner input (via customer calls, user groups, site visits, tradeshows, surveys, win/loss analyses, etc.) to understand market challenges and requirements.
• Ensure clear understanding of product supply (including regional allocation) working with Global Supply Chain and Global Marketing, and ensure allocation within region, and ensure customer satisfaction with resolution of any supply challenges.
• Ensure regional forecast accuracy for products in business units working closely with sales and demand planning.

Product Marketing Manager – Temperature Management

Account Executive

•Meet territory sales quota and effectively manage CRM pipeline for ICU Medical Infusion Therapy, Devices, Oncology, Specialty products, and Services
•Master presentation skills and share technical knowledge of the ICU family of products and how they relate to guidelines FDA, CDC, SHEA, INS, ONS, ASHP, etc. in order to communicate professionally with Hospital Clinicians
•Know the strengths and weaknesses of competing products in the market and how to position ICU Medical’s offerings against them clinically.
•Know the assigned territory and customer base, contracts, pumps, solutions, distribution models, etc.
•Be able to conduct product demos of all ICU products and conduct customer meetings
•Communicate with sales teams and managers to align sales efforts with Company and regional targets
•Support field sales in managing customer communications related to backorders, allocations, pricing, contracts, etc.
•Work on special projects as assigned and attend all team, regional, and office hours calls
•Travel outside of territory monthly to assist with educations, go-lives, implementations, assessments, etc.

Associate Hospital Sales Representative

• Develop and implement category strategies for logistics, warehousing, and transportation services, including identifying needs, project planning, collecting internal and external data, performing strategic analysis and identifying opportunities, formulating procurement strategies, and developing implementation plans.
• Form, lead, and facilitate cross-functional teams as applicable to execute the procurement process and plans; enable supplier selection and decision process; lead/facilitate contract development, negotiation and execution process.
• Establish should-cost models and benchmark rates across carriers and logistics providers.
• Manage strategy alignment, long term security of supply, supplier performance, and establish preferred supply base.
• Ensure optimal supplier pricing, supply responsiveness, quality, and contractual compliance.
• Develop appropriate risk management strategies which anticipate and address an extensive range of risk scenarios to assure supply of ICU Medical’s requirements.
• Maintain industry intelligence on technology trends, sourcing options, and competitive pricing.
• Measure and report on commodity performance objectives, monitor supplier performance, conduct periodic business reviews, and initiate corrective action when necessary.
• Review, negotiate, and maintain Supplier Agreements and supporting documentation.
• Benchmark prices and pricing information to ensure that the company is receiving the most cost-effective, highest quality products.
• Develop and maintain relationships with key stakeholders to support the sourcing process.
• Coordinate with other functions and impacted stakeholders to assure timely implementation and compliance with the agreed to sourcing strategies.
• Work on special assignments as they arise.

Global Category Manager – Logistics, Warehousing & Transportation

• Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.
• Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies. Makes independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory Management as appropriate.
• Acts as Global Regulatory Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements, and ensuring these requirements are incorporated into program deliverables.
• Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams. Author with team members, regulatory submissions for the Infusion Systems infusion pump product portfolio.
• Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes changes and present scientific rationale for ease of regulatory agency review.
• Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.

Manager, Regulatory Affairs

Learning and Development

• Drive sales excellence of the commercial teams by enhancing their knowledge, skills and competencies needed to drive business results.
• Work closely with cross-functional department leaders and stakeholders to assess education needs and market nuances and develop, modify, and deliver education to align to specific market or departmental needs.
• Analyze the effectiveness of education programs through review of education and facilitation delivery metrics, sales productivity reports, and learner/stakeholder feedback.
• Act as a subject matter expert to develop education content for internal and external audiences.

Learning & Development Partner

• Reporting to the Director of Commercial Operations & Strategy, the Manager, Associate Hospital Sales is responsible for leading and developing a team of Associate Hospital Sales Representatives.
• The primary responsibilities include the hiring, coaching, and development of Associate Hospital Sales Representatives to “field sales readiness,” while directing sales activities through a complex medical device sales process associated with driving growth in the respective region.
• This position increases revenue and profitability by expanding utilization of ICU Medical products throughout existing accounts.
• In addition, the Manager, Associate Hospital Sales must direct representatives to extend relationships into new accounts to increase year over year growth while working cross functionally with Field Sales, Marketing, Contract Marketing, Finance, Customer Care, and Services; and seek ways to inform the business.

Manager, Associate Hospital Sales

Business Intelligence Analyst

• Support the entirety of ICU Medical by developing and managing Supply Chain and Manufacturing data, dashboards and reports used to conduct analyses and assessments across all functions of the business
• Participate in requirements gathering sessions with key stakeholders to understand reporting needs and available data sources in the various areas of Supply Chain and Manufacturing
• Work with IT to migrate desired data into OBIEE data marts and/or Power BI workspaces
• Facilitate user acceptance testing for OBIEE/Power BI data migration initiatives, dashboards and reports
• Develop and manage multiple OBIEE, Power BI and Excel reports/dashboards using data from disparate data sources
• Build and maintain supply chain dashboards that consolidates KPI progress and analysis reporting in OBIEE/Power BI
• Administer repeated manual reporting tasks on cadence, without supervision, and with attention to quality, accuracy and timeliness
• Provide technical assistance and training to Operations end-users, including participating in recurring OBIEE/Power BI training programs and user-focused documentation development

Analyst, Operations Business Intelligence

• Participate in requirements gathering sessions with key stakeholders to understand reporting needs and available data sources in the various areas of Supply Chain (includes Logistics, Customer Care, Planning, Procurement, etc.) and Manufacturing
• Work with IT to migrate desired data into OBIEE data marts and/or Power BI workspaces
• Facilitate user acceptance testing for OBIEE/Power BI data migration initiatives, dashboards and reports
• Assist in ensuring data integrity across OBIEE, Power BI, and Excel-based reporting outputs
• Translate business requirements into specifications that will be used to develop required OBIEE/Power BI reports/dashboards and mailers, created from disparate data sources
• Develop and manage multiple OBIEE, Power BI and Excel reports/dashboards using data from disparate data sources
• Build and design layouts and visualizations to synthesize analytics into easy-to-understand value-driving opportunities
• Build and maintain supply chain dashboards (including inventory, logistics, demand planning, supply planning) that consolidates KPI progress and analysis reporting in OBIEE/Power BI
• Administer repeated manual reporting tasks on cadence, without supervision, and with attention to quality, accuracy and timeliness
• Automate repetitive offline reporting tasks as much as possible to streamline generation and delivery
• Document processes and cross-train other team members on administering and maintaining both manual and automated reporting
• Provide technical assistance and training to Operations end-users, including participating in recurring OBIEE/Power BI training programs and user-focused documentation development
• Troubleshoot and perform root cause analysis on user report issues
• Work on special projects, as needed

Operations Business Intelligence Analyst

• The Vascular Access Sales Specialist is responsible for building and maintaining ICU Medical’s Vascular Access & Blood Collection business in a given territory.
• The position is focused on increasing territory level profitability and expanding the current customer base by selling ICU Medical products and extending relationships into new areas with new customers.
• Provides post sales implementation support on an ongoing basis to ensure ICU Medical customers are maintaining an overall positive experience.
• The Vascular Access Sales Specialist will align with the Regional Sales Manager and coordinate daily activities to meet and exceed the annual territory Vascular Access and Blood Collection revenue objectives.
• Must be the clinical expert and consultative problem solver at the field level for clinical and supply chain contacts.
• Clearly communicate with Regional Sales Managers, Marketing and Operations Teams on product performance in order to drive better organizational performance on an ongoing basis.
• Meet and exceed all agreed upon annual ICU Medical organizational performance objectives for Vascular Access Sales Specialist role.
• Work on special projects as they arise and are assigned.

Vascular Access Sales Specialist

Engineer

• We are seeking a Biocompatibility Engineer II to join our team. As a member of the biocompatibility team, you will help ensure patient safety by contributing to the biological and toxicological evaluations of medical devices, materials, and processes. You will work closely with cross-functional teams to comply with global regulatory standards such as ISO 10993.
• You will leverage your understanding of the medical device biocompatibility field to provide guidance throughout the product development cycle, interpret regulatory requirements, and support the biocompatibility strategy. Using your analytical skills, you will review scientific data, identify gaps, and recommend risk mitigation strategies.
• This position will be pivotal in supporting regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with medical device regulations and standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, ISO 18562, and ISO 14971.

Engineer II, Biocompatibility

Analyst

• The IT Assurance Analyst provides CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality, as part of IT Quality and Compliance organizations.
• This role works closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures.
• Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary, coordinate other resources in validation documents and activities.

IT Assurance Analyst, QMS Applications

• Develop and implement category strategies for Facilities and MRO globally, including identify needs, project planning, collect internal and external data, perform strategic analysis and identify opportunities, formulate procurement strategies and develop implementation plans
• Form, lead, and facilitate cross-functional teams as applicable to execute the procurement process and plans; enable supplier selection and decision process; lead / facilitate contract development, negotiation and execution process
• Manage strategy alignment, long term security of supply, supplier performance, and establish preferred supply base
• Ensure optimal supplier pricing, supply responsiveness, quality, and contractual compliance
• Develop appropriate risk management strategies which anticipate and address an extensive range of risk scenarios to assure supply of ICU Medical’s requirements
• Maintain industry intelligence on technology trends, sourcing options, and competitive pricing
• Measure and report on commodity performance objectives, monitor supplier performance, conduct periodic business reviews, and initiate corrective action when necessary
• Review, negotiate, and maintain Supplier Agreements and supporting documentation
• Benchmark prices and pricing information to ensure that the company is receiving the most cost-effective, highest quality products
• Develop and maintain relationships with key stakeholders to support the sourcing process
• Coordinate with other functions and impacted stakeholders to assure timely implementation and compliance with the agreed to sourcing strategies
• Work on special assignments as they arise