Engineer II, Design Quality

Regulatory Jobs; San Clemente (CA); On-site; USD 71,000 - 102,000; Full time

Job summary

ICU Medical is seeking a Quality Engineer in California to support consumables development. You will participate in CAPA investigations, post‑market risk assessments, and design projects to ensure compliance with quality systems and regulations.

Work with cross‑functional teams to perform risk analyses, design verifications, and support audits. You will address on‑market issues and drive improvements to sustain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering (Electrical, Mechanical or Biomedical) required.
• Minimum of two years' experience in R&D and/or Quality.
• ASQ CQE certification preferred or obtainable within one year.

Responsibilities

• Lead CAPA investigations and post-market risk assessments.
• Support design projects and ensure compliance with ISO 13485, ISO 14971 and CFR 820.
• Assist with internal and external audits and inspections.
• Collaborate across cross-functional teams to improve product quality.
• Address on-market product issues and ensure timely resolution.
• Participate in design reviews and risk assessments.

Skills

Risk management

Quality systems

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

ASQ CQE

Job description

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

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

Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.