Engineer II, Design Quality (Hybrid - San Clemente, CA)

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., * 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 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, * 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.

• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5-10% of the time

Salary Range - $71,250 - $102,125

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

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.