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

About Us

ICU Medical consistently provides 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. Our focus includes 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, IV medication safety software, and significant US IV solutions manufacturing and supply capabilities.

About the Role

Provide quality support for ICU Medical Consumable development. The Quality Engineer will support activities such as CAPA investigations, design projects, and ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, including ISO 13485, ISO 14971, 21 CFR Part 820, and other relevant regulations.

Responsibilities

• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, and CAPA data to assure product quality.
• Assure conformance with regulations of the FDA and other international regulatory agencies.
• Provide compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
• 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.
• Maintain Design History Files (DHF) up to date as needed.
• Effectively interact with cross-functional team members.
• Provide quality support for on-market product issues, bringing issues to closure and escalating to management for support as necessary.
• Work on special projects as assigned.

Requirements

• 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, ISO 13485, MDSAP, EU MDR, and ISO 14971.
• Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.

Qualifications

• Must be at least 18 years of age.
• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field in engineering from an accredited college or university is required.
• Minimum of 4 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.

Pay

The salary range for this role is $90,000 - $129,000 annually. The actual salary may vary based on relevant experience, skills, education, licensure/certifications, and geographic location.

Benefits

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) an Annual Incentive Plan.
• A wide range of benefit options at affordable rates.
• Additional perks to assist employees with 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 ICU Medical Careers - Investing in Your Future.