New · posted Oct 15
ICU Medical · Medical Devices
Engineer II, Design Quality
- San Clemente, CA
- Hybrid
- Full-time
- Associate & Specialist
Open until filled
The role
Provide quality support for ICU Medical Consumables development. The Quality Engineer will support activities such as CAPA investigations, Post Market Risk Assessments, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.
What you need
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
- Minimum of two years of experience in R&D and/or Quality is required.
- ASQ CQE certification preferred or ability to obtain within one year.
Knowledge & Skills
- Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
- Knowledge of medical device standards.
- Knowledge of medical device standards, including but not limited to: ISO 13485 and ISO 14971
What you'll do
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Assures conformance with regulations of the FDA and other international regulatory agencies.
- Ensure all Quality attributes for design changes are met.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Support any potential internal and/or external audits and inspections.
- Effectively interact with cross-functional team members.
- Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
- Work special projects as assigned
Pay and benefits
$71,250 – $102,125 a year
Employer providedSalary Range - $71,250 - $102,125
401(k) match
Annual Incentive Plan
Paid Time Off
Company Holidays
Tuition Reimbursement
Health and welfare benefits
Where you'll work
San Clemente, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Clemente, CAWorking conditions
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5-10% of the time
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical provides a comprehensive total rewards package that includes:
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in California31 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $71,250 | — | $102,125 |
| California (middle half) | $77,000 | $80,000 | $96,500 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
This role: ICU Medical's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not ICU Medical's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk4
- GMP and compliance3
- Investigations and CAPA3
- Collaboration and leadership2
- Lab testing and methods1
- Documentation and SOPs1
- Validation and qualification1
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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Engineer II, Design Quality at ICU Medical
Open until filled. $71K–$102K a year, employer provided.