Jobs in the United States

25+ jobs

Save this search

Added just now
Simulation Engineer III - Material Handling Equipment (MHE)
KPI Solutions
Remote, United States
…sales and solution design, defend designs in front of customer engineering teams, de-risk systems before steel is ordered, and use emulation to shorten on-site commissioning. At Level III…
Added just now
Lead Process Architect
PS&S, LLC
Raleigh, NC
Founded in 1962, PS&S has evolved into a unique best-in-class architecture, engineering, surveying, and environmental consulting firm, providing design and consultation services to a wide…
Added just now
Sr. Process/Mechanical Engineer
PS&S, LLC
Raleigh, NC
We are seeking a highly experienced Senior Process or Mechanical Engineer to join our multidisciplinary engineering firm in the Triangle region. The ideal candidate brings deep technical…
Added just now
Construction Project Manager – Charter Schools (Charleston, SC)
Invoke Staffing
Charleston, SC
Our client, a leader in charter school development and construction across the Carolinas and Tennessee, is seeking an experienced Construction Project Manager to oversee charter school and…
Added 1 min ago
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
Senior Account Executive, SLED (IL/MO)
Cloudflare
Champaign, IL · Chicago, IL
…Internet application online without adding hardware, installing software, or changing a line of code. Internet properties powered by Cloudflare all have web traffic routed through its…
Added 1 min ago
Software Development Manager
Experian
United States
The Software Development Manager leads architecture and delivery for high-volume, high-transaction applications across Experian Health. This hands-on leadership role combines coding and…
Added 1 min ago
Lead Applied AI Engineer
STR
Woburn, MA · Arlington, VA
Systems engineering: Experience translating customer needs into requirements, designs, development and test plans, and integrated capabilities. Experience managing interfaces among…
Added 1 min ago
Lead Applied AI Engineer
STR
Arlington, VA · Woburn, MA
Systems engineering: Experience translating customer needs into requirements, designs, development and test plans, and integrated capabilities. Experience managing interfaces among…
Added 1 min ago
Senior Endpoint Engineer
CACI
Arlington, VA · Arlington
- Support Intune administration and engineering, to include compliance policies for conditional access, application deployment and patching, management and troubleshooting
Added 1 min ago
Senior Endpoint Engineer
CACI
Arlington, VA · Arlington
- Support Intune administration and engineering, to include compliance policies for conditional access, application deployment and patching, management and troubleshooting
Added 1 min ago
Senior Endpoint Engineer
CACI
Arlington, VA · Arlington
- Support Intune administration and engineering, to include compliance policies for conditional access, application deployment and patching, management and troubleshooting
Added 2 mins ago
Systems Engineer - New Grad (2027)
BAE Systems
Cedar Rapids, IA
As a part of our unique team, you will have responsibilities spanning all phases of the systems engineering life cycle including requirements, design, test development, integration,…
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
Commercial Destinations Office - Systems Engineer
Barrios Technology
Houston, TX
Apply engineering principles and techniques to requirements validation, product development, product integration, requirements verification, system validation, and hardware/software product…
Added 2 mins ago
E2E Connected Services Test Engineer
Stellantis
Auburn Hills, MI
Stellantis’s Software Organization (SWE) was established to build the most captivating experiences in the latest frontier of Automotive Technology. As part of that foundation, we are…
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 3 mins ago
A
Senior Technical Consultant - Forward Deployed Engineer, AI Security
AHEAD
Remote, United States
- $170,000 to $200,000 USD / year
…advances in cloud infrastructure, automation and analytics, and software delivery, we help enterprises deliver on the promise of digital…
Added 3 mins ago
Specialist, Software Engineer
L3Harris Technologies
Greenville, TX
Experience contributing to software development with cross-functional engineering teams within program cost, schedule, and technical constraints.
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
Senior Network Software Engineer
Leidos
Scott Air Force Base, IL
Leidos’ Digital Sector/Global Solutions Management-Operations II (GSMO-II) contract has an opening for a Senior Network Software Engineer located in the Scott AFB, IL area. The Senior…
Added 3 mins ago
Sr. Relay Technician
Electric Power Systems
Willowbrook, IL
Added 3 mins ago
Director Software Architect - Embedded AI
Honeywell
Atlanta, GA
8+ years of experience in software architecture, embedded software development, AI deployment, or related engineering roles.
Added 4 mins ago
Software Engineering & AI Intern
Leidos
Scott Air Force Base, IL
Leidos, a leading defense, intelligence, and technology company, is seeking motivated and aspiring software engineering students for ourSummer 2027 Internship Program (Starts May 2027). As…
Added 4 mins ago
Structural Machine Operator
Nucor Steel Auburn, Inc.
El Paso, IL
…meaningful work and focus heavily on both personal and professional development. Whether your background is in engineering and design, information technology and software development,…

ICU MEDICAL INC

Quality Engineer II, Sustaining & Validation

SALT LAKE CITY, UT, United States

Apply About employer

Applications open in a new tab.

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

Apply About employer

More about this job

Skills

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

Report this job