Position Summary
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.
Essential Duties & Responsibilities
- 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
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
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.
Work Environment
- 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
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems 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.
- Significant US IV solutions manufacturing and supply capabilities.
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 [email protected]. 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
Skills Required
- At least 18 years of age
- Bachelor's degree in Electrical, Mechanical, Biomedical Engineering, or a related field from an accredited college or university
- Minimum of two years of experience in research and development and/or quality
- Knowledge of Quality Management Systems and risk management integration across Design Controls, CAPA, Complaints, and Document Control
- Knowledge of medical device standards, including ISO 13485 and ISO 14971
- ASQ CQE certification or ability to obtain it within one year
ICU Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICU Medical and has not been reviewed or approved by ICU Medical.
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Retirement Support — Retirement offerings include a 401(k) with a company match and mentions of immediate vesting in some cases. Feedback suggests this component is one of the more reliable strengths of the package.
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Leave & Time Off Breadth — Paid time off and holidays are consistently highlighted as stronger elements within the benefits mix. Feedback suggests time-off policies compare favorably relative to other benefit areas.
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Healthcare Strength — Core coverage spans medical, dental, and vision alongside HSA/FSA and life/disability options. Feedback suggests the breadth is comprehensive even if the depth feels average in places.
ICU Medical Insights
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care. For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care. 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. > Significant US IV solutions manufacturing and supply capabilities.
