Engineer III, Design Quality

Engineer III, Design Quality

ICU Medical is seeking an Engineer III, Design Quality. Provide quality support for ICU Medical Hardware and 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, 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.
• Assure conformance with regulations of the FDA and other international regulatory agencies.
• Provide compliance guidance concerning development, application, and maintenance of quality standards 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; bring issues to closure and escalating to management for support as necessary.
• Work on 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, ISO 13485, MDSAP, EU MDR and ISO 14971.
• Knowledge in statistics (tolerance limits, Cpk, etc.) and Minitab is preferred.

• 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.
• Minimum of 4 years of experience in R&D and/or Quality.
• ASQ CQE certification preferred or ability to obtain within one year.

• This is largely a sedentary role.
• The 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 – $90,000 – $129,000. The salary range displayed represents the annual base salary we reasonably expect to pay for this role. Actual salary may vary based upon factors such as experience, skills, education, licensure/certifications, and geographic location.

ICU Medical provides a comprehensive total rewards package that includes a competitive 401(k) match, Annual Incentive Plan (for eligible roles), a wide range of benefit options at affordable rates, Paid Time Off, Company Holidays, Tuition Reimbursement, and additional perks to assist employees with work‑life effectiveness.

ICU Medical is a global market leader in IV therapy and critical care products, with a complete line of clinically‑essential IV therapy and high‑value critical care products for hospital, alternate site, and home care settings.

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at  We are committed to providing equal access and opportunities for all candidates.