New · posted Oct 15
ICU Medical · Medical Devices
Quality Engineer II, Sustaining & Validation
- Salt Lake City, UT
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
- 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).
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.
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 occasionally move and lift objects of up to 25 lbs
- Typically requires travel less than 5% of the time
What you'll do
- 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 company 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.
Where you'll work
Salt Lake City, UTOn-siteOpen in Maps (opens in a new tab)
More jobs in Salt Lake City, UTJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $110,750 | $121,000 | $132,500 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 111 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not ICU Medical's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification9
- Quality systems and risk7
- Collaboration and leadership5
- GMP and compliance4
- Documentation and SOPs4
- Data and digital systems4
- Lab testing and methods3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
ICU Medical on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 4
- Locations
By discipline
- Quality6 86%
- Regulatory1 14%
By level
- Associate & Specialist4 57%
- Senior & Principal3 43%
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Quality Engineer II, Sustaining & Validation at ICU Medical
Open until filled.