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

ICU Medical; San Clemente (CA); On-site; USD 90,000 - 129,000; Full time

Benefits offered by this job

401(k) match

Benefits options

Paid time off and holidays

Job summary

ICU Medical is seeking a Quality Engineer to support consumable development and ensure compliance with ISO 13485, 21 CFR Part 820, and related standards. You will participate in design reviews, risk assessments, and CAPA data handling while maintaining DHF quality and guiding cross-functional teams.

The role emphasizes strong knowledge of quality systems, risk analysis, and statistical methods (Minitab) to drive product quality improvements and audit readiness across global regulatory

Qualifications

• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field is required.
• ASQ CQE certification preferred or ability to obtain within one year.
• Experience with quality systems and design controls preferred.

Responsibilities

• Support CAPA investigations and quality system compliance for ICU Medical consumable development.
• Ensure conformance with FDA and international regulatory requirements.
• Provide guidance on quality standards across product development within the quality system.

Skills

Quality management systems

Design controls

CAPA

Risk analysis

Statistics

Minitab

Education

Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field

ASQ CQE certification preferred or ability to obtain within one year

Tools

Minitab

Job description

Position Summary

Provide quality support for ICU Medical Consumable development. The Quality Engineer will support activities such as CAPA investigations, 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.
• Provides 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 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, ISO 13485, MDSAP, EU MDR and ISO 14971.
• Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.

Minimum Qualifications, Education & Experience

• 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

Salary

Salary Range - $90,000 - $129,000

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.

Benefits

• 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

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