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Added 1 min ago
Senior Environmental Due Diligence Professional
Arcadis
Highlands Ranch, CO
Arcadis is seeking an Environmental Due Diligence (EDD) Senior Technical Expert (Environmental Scientist, Environmental Engineer, or Environmental or Health & Safety area disciplines) to…
Added 1 min ago
Engineer 4, Software Development & Engineering-5646
Comcast (CC) of Willow Grove
PA
…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 for the…
Added 1 min ago
Continuous Improvement Engineer
Analogic Jobs US
Vista, CA
Analogic is seeking a Continuous Improvement Engineer for the Homeland business unit in Vista, CA. The Homeland business unit at Analogic designs and manufactures highly complex security…
Added 1 min ago
B&
Civil Engineer - Water
Black & Veatch Family of Companies
Tualatin, OR
- $86,909 to $145,142 USD / year
…complex projects. Communicate client interests and drivers to project team members and develops approaches to accommodate these concerns in the performance of the work on less complex…
Added 1 min ago
Electrical Superintendent - Combined Cycle - Oklahoma
Black & Veatch Family of Companies
Beech Island, SC · Claude, TX · Lawton, OK
From field engineering to project management to quality and startup, you’ll work with cutting‑edge technology, learn from seasoned experts, and grow through real‑world, hands‑on experience.…
Added 2 mins ago
Supplier Quality Engineer
Bosch Group
Lincolnshire, IL
The Supplier Quality Engineer is responsible for communicating and delivering the requirements of the HydraForce Supplier Quality Assurance Manual to the supply base. Ensuring all quality…
Added 3 mins ago
KS
Simulation Engineer III - Material Handling Equipment (MHE)
KPI Solutions
Remote, United States
- $125,000 to $150,000 USD / year
The Simulation Engineer III builds and validates discrete-event simulation and emulation models of automated material handling systems - conveyor and sortation, AS/RS and shuttle systems,…
Added 3 mins ago
Senior Pre-Sales Infrastructure/Network Design Engineer
ewminds consulting Services
New York, NY
Project and Sprint Management: Manage multiple design engagements simultaneously and deliver quality work within sprint timelines.
Added 4 mins ago
CNC Tooling Sales and Application Engineer
Kennametal, Inc.
Ann Arbor, MI
Proactively managing the complete sales process, including prospecting, qualification, consultative sales meetings, product demos, pricing, terms negotiations, and sourcing.
Added 4 mins ago
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Senior Electrical Engineer
GPAC
Columbus, OH
- $12,500 to $165,000 USD / year
Function as lead electrical engineer for multi-discipline projects, through all phases of process
Added 5 mins ago
R
Project Engineer, HVAC Control Systems
Ramboll
Los Angeles, California, CA
- $100,000 to $125,000 USD / year
As our new Control Systems Engineer within the Data Center Facilities Group, you will be a part of Ramboll’s diverse, creative, and collaborative team. When you start with Ramboll, you will…
Added 6 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 7 mins ago
Manufacturing Engineer
Alliant Power
Denver, CO
…Minimum of 5 years of related work experience. Strong product/process design, application and system testing aptitude. Demonstrated ability to utilize structured project management…
Added 9 mins ago
IT Support Engineer (Desktop & Linux)
Riverlane
Boston, MA
We’ve got a great opportunity for a customer-facing IT Support Engineer, who enjoys rolling up their sleeves and making technology work for people.
Added 9 mins ago
2027 Principal Guidance Navigation Control Engineer - Dulles VA
SP - Orbital Space Systems
United States
Apply engineering principles, industry standards, company process, and knowledge of vehicle dynamics, aerodynamics, propulsion, classical/modern control, and estimation theory to perform…
Added 10 mins ago
Senior Preconstruction Manager - Commercial - Greenville, SC
Reeves Young LLC
Greenville, SC
…subcontractors, bid packages, the subcontractor/supplier bid process, evaluation of bids, presentation of detailed estimates of work, and developing strategies to win & execute…
Added 11 mins ago
Experienced Injection Molding Engineer
Johnson & Johnson Vision Care, Inc. Legal Entity
Jacksonville, FL
…designs for manufacturability and cost-effectiveness. Maintain process documentation, including setup sheets, validation protocols, and work instructions. Ensure that supply chain…
Added 11 mins ago
Staff Manufacturing Engineer -Orthopaedic
MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity
West Chester, PA · Raritan, NJ
The successful candidate will be working within a cross-functional project team through all phases of the product development process, planning and executing projects through the product…
Added 13 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 13 mins ago
Power System Panel Design Engineer - Grid Automation
GE Grid Solutions, LLC
United States
GE Vernova’s Grid Automation Control & Protection panel design engineer is a hands-on, high-impact engineering role responsible for owning the design, programming, testing, and…
Added 13 mins ago
Senior Instrumentation and Controls Engineer
X-Energy, LLC
Rockville, MD
X-energy LLC conducts a thorough recruiting process and will never issue offers without interview to discuss qualifications and responsibilities. All applications will be submitted via our…
Added 14 mins ago
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Piping Engineer
Actalent
Downers Grove, IL
- $35 to $48 USD / hour
Job Title: Piping Engineer (Stress Engineer I)Job DescriptionThis early-career Piping Engineer role focuses on piping stress analysis, system flexibility, piping supports, and mechanical…
Added 14 mins ago
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Project Manager
Actalent
WATERVLIET, NY
- $52 to $67 USD / hour
Document and manage all project correspondence, including submittal management, RFI management, and legal notices, with the owner, engineer, subcontractors, and vendors.
Added 14 mins ago
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PCB Design Engineer Secret Clearance
Actalent
Owego, NY
- $60 to $72 USD / hour
…guaranteed. Contract extensions may also be possible depending on project requirements.Pay: $60-$72/hrWe are seeking a PCB Design Engineer with an active Secret Clearance to support the…
Added 14 mins ago
A
Antenna Test Engineer
Actalent
LINTHICUM HEIGHTS, MD
- $43.27 to $76.92 USD / hour
Job Title: Antenna Test Software EngineerJob DescriptionThe Antenna Test Software Engineer develops and supports automated test solutions for advanced phased array antenna systems within a…

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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