Position Summary

The Configuration Specialist is responsible for routine and advanced tasks related to creation, maintenance, and updates to products throughout its lifecycle.

This is a hybrid role and may be based in Minneapolis, MN or Salt Lake City, UT.

Essential Duties & Responsibilities

• Manage device master records (DMRs) activities such as item entry, maintenance and Lifecycle changes in AGILE PLM, Setmaker and Oracle EBS systems in compliance with company procedures, GMP, and all National and International Quality Standards
• Maintain all master documents including BOM, product drawings, specifications and procedures
• Create and maintain device Bill of Materials (BOM) and routers
• Create and maintain device Identifier records in Agile system Create device designs using SetMaker application as applicable.
• Coordinate, monitor and publish UDI/ GDSN records at the corresponding systems and regulation agencies platforms.
• Lock and unlock SetMaker configurations as applicable.
• Maintain SetMaker database and stencils.
• Perform Agile, Oracle and SetMaker mass updates utilizing tools such as Dataloads and More4apps
• Perform SetMaker item conversions
• Prepare, route, monitor, and implement Engineering Change Orders (ECOs) in corresponding systems for both New DMR releases and changes to existing Items
• Coordinate and request the application of redlines to process orders based on an approved ECO
• Cross check, audits Engineering Change Order (ECO) in the corresponding systems
• Coordinate engineering change proposals and the Change Control Review Board (CCRB)
• Retrieve, view, edit, and print Agile documents
• Audit files to ensure these are matching with current revision in Agile and Oracle
• Review and approve DMR records and documents electronically
• Inactivate and reactivate items parts and document records in Agile and Oracle
• Follow the annual system maintenance plan to ensure the product data is accurate and information is in synch within QMS and EBS systems.
• Understand and use the SetMaker web tools and applications
• Support internal and external audits and in spections.
• Support Production and Operations for solving product configuration issues
• Work on special assignments as they arise

Knowledge & Skills

• Proficient in Excel, Word, and Outlook
• Excellent verbal and written communication skills
• Ability to multitask and work in a fast-paced environment
• High level of attention to detail
• Strong organizational skills

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• High school diploma is required
• Bachelor's degree from an accredited college or university is preferred
• Minimum 3 years of experience in a Configuration Support role or equivalent
• Experience with an ERP system
• Experience in medical device manufacturing or sales
• Experience in engineering drawing, marketing, or customer service

Salary Range - $53,600 - $72,025

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

ICU Medical provides a comprehensive total rewards package that includes:

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their w ork-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

"Know Your Rights" Poster Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants