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Information Security Systems Engineer (ISSE)
Peraton
Chantilly, VA
The Information System Security Engineer is responsible for designing, implementing, maintaining, and continuously improving the security posture of the organization’s information systems,…
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Manufacturing Software Engineer Intern
Veolia Environnement SA
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The Manufacturing Software Engineer Inter will be responsible for developing and maintaining software and reports specifically used in manufacturing environments. This role focuses on…
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Lead Quality Engineer - Consumables
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Drive and establish process validation, monitoring and control at critical suppliers and internally using data analysis software tools (e.g. JMP) and conduct Design of Experiments for…
Added 1 min ago
Senior Principal Engineer – Instrument & Controls
T.EN
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The Senior Principal Engineer – Instrument & Controls develops, supports, and leads instrumentation and control systems engineering and design deliverables for complex EPC projects in LNG,…
Added 2 mins ago
O
Field Engineer I
Optimum
Lindenhurst, NY
- $57,802 to $94,960 USD / year
The Field Engineer I provides hands‑on, on‑site network engineering support (“Network Smart Hands”) for the Access and CPTO networks. This role is responsible for supporting installations,…
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Commercial Account Executive
Tacton
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Added 3 mins ago
Condition Monitoring Engineer or Vibration/Technical Specialist
Smiths Group
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Mechanical Engineer or Mechanical Engineering Technology degree preferred and/or equivalent and relevant work experience with rotating equipment for the Condition Monitoring Engineer…
Added 3 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 3 mins ago
Civil/Environmental Engineer, PE
WSB LLC
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Forge Ahead with WSB! We are seeking a Civil or Environmental Engineer to join our growing team in Idaho and be involved with complex environmental and civil projects that make a lasting…
Added 4 mins ago
Project Controls Manager
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…people's lives. We are the leading provider of sustainable Engineering, Architecture, Construction and Consulting solutions to the global life sciences and food and beverage industries. Our…
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Information Systems Security Engineer
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Rockville, MD
CSEngineering is seeking an experienced Information System Security Engineer to join our growing team! This position will support the Indian Health Service (IHS), Division of Information…
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Intern: Manufacturing Engineer (Summer 2027)
Volvo Group
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Senior Systems Engineer
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Cleveland - 44135, OH
NASA Glenn Research Center, under the SpaceDOC-III contract, is seeking a Systems Engineer with 15+ years’ experience in spaceflight project engineering support in system architecture…
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Engineer - Project Engineer-Design Lead
Eli Lilly and Company
United States
Pharmaceutical process or project engineer experience.
Added 5 mins ago
Associate Director - Project Management - GFD
Eli Lilly and Company
United States
· Bachelor of Science in an engineering field or a field related to project management.
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Server Virtualization Platform Operations Engineer
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The Cloud and Connectivity organization is actively looking for a VMware ESX Platform Operations Engineer to join them. Do you like to solve challenges and have an interest in large scale…
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Business Development Director (RCG)
Ciklum
United States
We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over…
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TEKsystems
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- $60 to $80 USD / hour
DescriptionTEKsystems is currently seeking a Radar Firmware Engineer to join our us on an exciting and cutting-edge radar program. The ideal candidate will be able to take…
Added 6 mins ago
Senior Environmental Due Diligence Professional
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Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
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Engineer 4, Software Development & Engineering-5646
Comcast (CC) of Willow Grove
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…plugins that are necessary to improve the software release engineering process; manage risks and resolve issues that affect release scope, schedule and quality; serve as the primary liaison…
Added 6 mins ago
Continuous Improvement Engineer
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Civil Engineer - Water
Black & Veatch Family of Companies
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…innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are building a world of…
Added 6 mins ago
Electrical Superintendent - Combined Cycle - Oklahoma
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Beech Island, SC · Claude, TX · Lawton, OK
…innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are building a world of…
Added 7 mins ago
Supplier Quality Engineer
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Added 8 mins ago
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We are sourcing candidates for a Civil Designer position in our White Plains office designing plans for municipal engineering projects.

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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