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Added 2 mins ago
Senior Software Engineer/Developer
Na Ali'i Consulting & Sales, LLC.
United States
Nakupuna Companies is looking for a Senior Software Engineer/Developer to provide Naval Supply Systems Command (NAVSUP) Business Systems Center (BSC) contractor support services to support…
Added 5 mins ago
Senior Environmental Due Diligence Professional
Arcadis
Highlands Ranch, CO
…established EDD Community of Practice (CoP) by supporting the production of high-quality Phase I Environmental Site Assessments (Phase I ESAs) in accordance with the ASTM International…
Added 5 mins ago
Continuous Improvement Engineer
Analogic Jobs US
Vista, CA
The Continuous Improvement Engineer will be responsible for directly supporting the manufacturing team by developing processes that increase production efficiency and reduce manufacturing…
Added 8 mins ago
I(
Database Application Engineer
IBR (Imagine Believe Realize)
Suitland, MD
- $110,000 to $130,000 USD / year
The Database Application Engineer will serve as the application team’s primary point of contact with the infrastructure DBA team. The Database Application Engineer will define application…
Added 9 mins ago
Mechanical Engineer, Support Systems
Anduril Industries
Costa Mesa, CA
…turns thousands of data streams into a realtime, 3D command and control center. As the world enters an era of strategic competition, Anduril is committed to bringing cutting-edge autonomy,…
Added 11 mins ago
Digital Design Engineer
Pole/Zero LLC
West Chester, OH
As a Digital Design Engineer at Microwave Products Group – Pole/Zero Corporation in West Chester, OH, you will support the military community by being responsible for developing and…
Added 14 mins ago
2027 Principal Guidance Navigation Control Engineer - Dulles VA
SP - Orbital Space Systems
United States
We are looking for motivated GNC (Guidance, Navigation, and Control) engineers who want to solve interesting, complex problems, which protect our nation. Our GNC team is designing,…
Added 14 mins ago
Senior Embedded Engineer
EquipmentShare
Columbia, MO
Build the Future with Us - EquipmentShare is Hiring a Senior Embedded Engineer
Added 15 mins ago
Staff Site Reliability Engineer
ACV Auctions
Buffalo, NY
We’re looking for a Staff Site Reliability Engineer to set the technical direction for reliability across ACV’s engineering organization. You’ll work alongside infrastructure, platform,…
Added 16 mins ago
RA
Quality Engineer - Assembly
RADIUS AEROSPACE INC
Hot Springs, AR
- $60,000 USD / year
The Quality Engineer develops, modifies, applies, and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials…
Added 17 mins ago
Member of Technical Staff (Storage)
Cockroach Labs
Remote, United States
We’re looking for a Staff Software Engineer to join our Storage Team to help shape and build CockroachDB’s storage systems. Storage is the foundation of CockroachDB, responsible for the…
Added 18 mins ago
Electrical Engineer
Actalent
Gilbert, AZ
Job Title: Electrical Engineer Aerospace and DefenseJob DescriptionThis role designs, develops, analyzes, and documents complex electrical systems, subsystems, and components for aerospace…
Added 18 mins ago
A
Manufacturing Engineer
Actalent
REYNOLDSBURG, OH
- $31.25 to $36.06 USD / hour
Job Title: Manufacturing EngineerJob DescriptionThe Manufacturing Engineer will perform a wide range of electro-mechanical and multi-trade functions focused on the installation,…
Added 18 mins ago
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Quality Engineer
Actalent
Lebanon, OH
- $40.87 to $52.89 USD / hour
Job Title: Quality EngineerJob DescriptionThe Quality Engineer will play a vital role in supporting the development of quality systems, improving supplier processes, and ensuring customer…
Added 18 mins ago
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Manufacturing Engineer
Actalent
Blue Ash, OH
- $80,000 to $125,000 USD / year
Job Title: Manufacturing EngineerJob DescriptionThis Manufacturing Engineer role focuses on developing, improving, and supporting custom part manufacturing within the aerospace industry.…
Added 18 mins ago
A
Principal Embedded Software Engineer
Actalent
Oshkosh, WI
- $70 to $85 USD / hour
Job Title: Principal Embedded Software EngineerJob DescriptionThe Principal Embedded Software Engineer designs, develops, and integrates embedded software for advanced vehicle control…
Added 18 mins ago
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Hardware Engineer
Actalent
Winamac, IN
- $80,000 to $120,000 USD / year
…seamless integration of the hardware into the overall vehicle control system, contributing directly to…
Added 19 mins ago
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Electrical Designer
Actalent
Austin, TX
- $40 to $52 USD / hour
Job Title: Electrical Controls DesignerJob DescriptionThis role focuses on the design, documentation, and quality control of industrial control systems and electrical assemblies. You will…
Added 21 mins ago
Associate Software Engineer (Hybrid)
Vizient, Inc.
Irving, TX
Vizient is seeking an entry-level Software Engineer to contribute to the design, development, testing, and delivery of scalable, secure, and user-centered software solutions.
Added 26 mins ago
Production/Commissioning and Start-Up Engineer
Chart Industries
Orem, UT
We are seeking a dynamic and experienced Production/Commissioning and Start-Up Engineer to join our team at our Orem, UT location, developing the Cryogenic Carbon Capture process. This role…
Added 26 mins ago
Sentinel - Systems Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Defense Systems is seeking a Systems Engineer to join our team. This position will be located at Roy, UT to support the Sentinel (GBSD) program in the Strategic Deterrent…
Added 26 mins ago
Quality Engineer II, Sustaining & Validation
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 26 mins ago
Quality Engineer II, Sustaining
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 29 mins ago
Principal Field Service Engineer
PulseForge, Inc.
Austin, TX
Principal Field Service Engineer – Austin Texas Location
Added 34 mins ago
Manufacturing Engineer
Bosch Group
Florence, KY
The Manufacturing Engineer will be responsible for supporting the planning of new equipment and processes within the Electric Rack Steering assembly area. This position supports equipment…

ICU MEDICAL INC

Quality Engineer II, Sustaining & Validation

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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