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Mechanical Engineer I
Quanta Power Solutions, LLC
Birmingham, AL
Quanta Power Solutions is seeking a motivated Mechanical Engineer I to support the design and development of mechanical systems for power generation, renewable energy, battery energy…
Added 1 min ago
Lead Applied AI Engineer
STR
Woburn, MA · Arlington, VA
As a Lead Applied AI Engineer, you will lead the technical development and delivery of RF AI/ML-based tools, algorithms, and software integrated with physical hardware, sensors, and…
Added 1 min ago
Lead Applied AI Engineer
STR
Arlington, VA · Woburn, MA
As a Lead Applied AI Engineer, you will lead the technical development and delivery of RF AI/ML-based tools, algorithms, and software integrated with physical hardware, sensors, and…
Added 1 min ago
Maintenance Lead
Carlisle
Aurora, Colorado, CO
We’re equally committed to our people, prioritizing safety, inclusion, career growth, development, tuition assistance, and excellent benefits.
Added 1 min ago
Systems Engineer - New Grad (2027)
BAE Systems
Cedar Rapids, IA
Solid understanding of systems engineering development process
Added 2 mins ago
Engineer, Software Engineering
Flagship Pioneering, Inc.
Cambridge, MA
FL103 is seeking an Engineer, Software Development to help design and evolve our biological research platform. The successful candidate will work with the computational modeling and…
Added 2 mins ago
Software Quality Assurance Engineer
Stellantis
Auburn Hills, MI
The Software Quality Assurance Engineer mission is to ensure the projects compliance to internal development process, and that internally developed software meets the software industry…
Added 2 mins ago
Hotel Maintenance Engineer
Schulte Companies
Nashville, TN
Schulte Hospitality Group is seeking an energetic, experienced, and hands on Maintenance Engineer to join our team! SHG is an organization whose success is rooted in its service culture.…
Added 2 mins ago
Housekeeping Supervisor | Hotel Cala
Schulte Companies
Tampa, FL
…inclusive, employee-focused workplace that is invested in your development. We want you to feel engaged, empowered, and excited to grow with us. After all, we believe our greatest and most…
Added 2 mins ago
RU
Data Engineer
Randstad USA
Smithfield, RI
- $69 to $70 USD / hour
· Hands-on experience with API design & development, AWS (Cloud) Development/Migration, Data Design, Batch Processing, Workflow/Process Automation and UI
Added 2 mins ago
RU
Full Stack Engineer (50/50 or 60/40 split)
Randstad USA
Roanoke, TX
- $71 to $72 USD / hour
- Experience in Agile and Scrum development methodology.
Added 2 mins ago
A
Senior Technical Consultant - Forward Deployed Engineer, AI Security
AHEAD
Remote, United States
- $170,000 to $200,000 USD / year
The Senior Technical Consultant (Forward Deployed Engineer) for AI Security is a senior, customer-facing technical engineer responsible for deploying, integrating, and operationalizing AI…
Added 3 mins ago
Specialist, Manufacturing Engineer
L3Harris Technologies
Waco, TX
L3Harris is seeking an Industrial Engineer Level 3 to support manufacturing operations in Waco, Texas. This role combines product-line layout and manufacturing process engineering to…
Added 3 mins ago
Supply Chain Engineer III
NFI Industries
Irving, TX
The Supply Chain Engineer III will manage the development of engineering analysis and implementation of engineering projects to direct ongoing continuous improvement and solve supply chain…
Added 3 mins ago
I
Field Service Engineer
ITW
Chicago, IL
- $35 to $38 USD / hour
…and offers exceptional opportunities for personal and career…
Added 3 mins ago
Senior Network Software Engineer
Leidos
Scott Air Force Base, IL
…(GSMO-II) contract has an opening for a Senior Network Software Engineer located in the Scott AFB, IL area. The Senior Network Software Engineer will support the development and release of…
Added 3 mins ago
Software Engineering & AI Intern
Leidos
Scott Air Force Base, IL
…mission-critical scale. You will work with high-volume data, engineer real-time pipelines using technologies such as Kafka and Elastic, and apply predictive machine learning and generative…
Added 3 mins ago
Structural Machine Operator
Nucor Steel Auburn, Inc.
El Paso, IL
Operational knowledge of machines and process in the structural department such as but not limited to shear, auto beam welder, plate line, flange lines, tack station, small parts, CNC…
Added 3 mins ago
Structural Design Engineer
Nucor Steel Auburn, Inc.
El Paso, IL
…cost-effective metal building systems. As aStructural Design Engineer, you'll play a crucial role in the design process, ensuring that each project meets our high standards of quality and…
Added 3 mins ago
Supply Chain Planning Engineer
Caterpillar, Inc.
Morton, IL
As a Supply Chain Planning Engineer, you will be responsible for supporting the global rollout and implementation of a new SAP S/4 order management solution . You will partner with business…
Added 3 mins ago
Test & Validation Engineer
Caterpillar, Inc.
Mossville, IL
As an Engineer supporting the Large Power Systems Division (LPSD), you will help drive engine compliance, certification, and testing activities across diesel, Dynamic Gas Blending (DGB),…
Added 3 mins ago
GH
Project Manager - Patient Care Solutions
GE HealthCare
Remote, United States
- $112,000 to $168,000 USD / year
…team, you'll own the project management and implementation process for GE HealthCare Patient Care Solutions which include Monitoring Solutions, Perioperative and Maternal Infant Care…
Added 3 mins ago
E
Sr Project Manager
Exelon
OAKBROOK TERRACE, IL
- $100,800 USD / year
…Leads project teams through business case / capital approval process, development and execution of project plans and project closeout. These projects have budgets that will typically range…
Added 4 mins ago
Sr. Molding Engineer
Actalent
Buffalo Grove, IL
As a Sr. Molding Engineer, you will be responsible for the development, optimization, and maintenance of robust molding processes for liquid silicone rubber (LSR) and high consistency…
Added 4 mins ago
C
Building Engineer
CBRE
Mettawa, IL
- $85,000 to $100,000 USD / year
As a CBRE Building Engineer, you will be responsible for monitoring, maintaining and repairing building system operations and the performance of various areas including plumbing,…

ICU MEDICAL INC

Quality Engineer II, Sustaining

SALT LAKE CITY, UT, United States

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Job details

Education: Bachelor’s degree
Posting language: English
Posted: Nov 10, 2026

Original job description

Job Description Position Summary This role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products meet the highest standards of quality and regulatory compliance. The Quality Engineer II, Sustaining will work closely with cross-functional teams, including R&D, Advanced Manufacturing Engineering, Manufacturing, and Quality Assurance, to validate equipment, processes, and software used in production. Essential Duties & Responsibilities - Demonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products. - Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems. - Conduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation. - Create and review Quality Control Plans and process FMEA's, - Ensure validation documentation is accurate, complete, and in accordance with regulatory and quality system requirements. - Maintain validation master plans, protocols, and reports as part of the company's quality system documentation. - Improve the Quality Management System through internal audits and supporting regulatory audits. - Lead and support the validation of new and existing manufacturing processes, ensuring compliance with FDA regulations, ISO 13485 standard, and compa ny quality systems. - Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed - Must be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform analysis and resolve problems of moderate complexity. - Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements. - Updates Standard Operating Procedures and related QMS documentation, to complete improvement projects, as required. - Establish and maintain communication both internal and external (with the customers, molding, automation, assembly, product engineering, project management and regulatory personnel as needed) - Continually improve knowledge of relevant quality/regulatory topics and changes. Knowledge, Skills & Qualifications - Knowledge of Agile PLM / Oracle (Desirable) - Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts. - Proficient in Minitab and Microsoft Office Suite - Strong communication skills and the ability to work collaboratively with cross-functional teams. - Able to multitask and work in a fast-paced environment. - High level of attention to detail and strong organizational skills. Education and Experience - Must be at least 18 years of age - Bachelor's degree in STEM from an accredited college or university - 2-4 years' experience working in a regulated manufacturing or pharmaceutical/healthcare environment required. Prior experience in quality is preferred. - Proficiency in using validation software and other relevant tools (e.g., Minitab, statistical analysis software). - Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485). Physical Requirements and Work Environment - This is largely a sedentary role. - This job operates in a professional office environment and routinely uses standard office equipment. - Work is partly performed in a clean room environment - Must be able to occasional ly move and lift objects of up to 25 lbs - Typically requires travel less than 5% of the time About Us ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Syst ms 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. ICU Medical EEO Statement: ICU Medical is committed to being an 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, 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 Know Your Rights: Workplace Discrimination is Illegal Poster ICU Medical CCPA Notice to Job Applicants

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Skills

Apply advanced manufacturing
Quality assurance
Agile
PLM
Oracle
Minitab
Microsoft Office
Communication skills
Multitask
Attention to detail
Organizational skills
EHR

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