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 and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance. Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system. Work with cross-functional teams to coordinate product changes. Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc. Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary. Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality. Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks. Ensure compliance, alignment and consistency with ICU Medical’s quality system. Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections. Work special projects as assigned. *Hybrid work from home is permissible. When not working from home, must report to San Clemente, CA office. *5-10% domestic and international travel required per year.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelor’s degree (or foreign equivalent) in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field plus Seven (7) years of experience in the job offered or a closely related occupation.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time.” Required expertise/knowledge includes: Knowledge of the Medical Device Industry and experience in ISO and FDA QSR regulations, including ISO 13485 and ISO 14971; Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System, including Design Controls, CAPA, Complaints, and Document Control; Experience in managing Design Control elements, Design History Files and Device Master Records; Experience in supporting 510K and Technical File submissions; Experience in creating Design V&V protocols and reports; Experiences in initiating and managing Risk Management documents (HA, DFMEA, PFMEA); Familiarity with international regulations including REACH and RoHS compliances; Experience in investigations, risk assessments and associated CAPA activities; Knowledge in Statistical Analysis Techniques; Experience with Quality compliance, audit and investigation.
ICU Medical, Inc. is an equal opportunity employer.
40 hours per week / $140,774 - $161,000 per year
To apply for ICU Medical’s Senior Engineer, Design Quality position please send resume to: [email protected]
Must reference JOB CODE: CA0606PS
Skills Required
- Bachelor's degree in Electrical, Mechanical, Biomedical, Software Engineering, or closely related field plus seven (7) years relevant experience
- Knowledge of the Medical Device Industry and experience with ISO and FDA QSR regulations
- Experience with ISO 13485 and ISO 14971
- Knowledge of Quality Management Systems and linking risk management to Design Controls, CAPA, Complaints, and Document Control
- Experience managing Design Control elements, Design History Files (DHF) and Device Master Records (DMR)
- Experience supporting 510(k) and Technical File submissions
- Experience creating Design V&V protocols and reports
- Experience initiating and managing Risk Management documents (Hazard Analysis, DFMEA, PFMEA)
- Familiarity with international regulations including REACH and RoHS
- Experience in investigations, risk assessments and associated CAPA activities
- Knowledge of Statistical Analysis Techniques for monitoring product data and trends
- Experience with quality compliance, audits and inspections
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.
-
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.
-
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.
-
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.
