ICU Medical · 2 days ago
Engineer III, Design Quality
San Clemente, CA
Full-time
Onsite
Mid Level
$90K/yr - $129K/yr
4+ years expICU Medical is a global market leader in IV therapy and critical care products. The Quality Engineer will provide quality support for hardware and consumable development, ensuring compliance with quality system requirements and applicable regulations.
Health CareMedical Device
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
Qualification
Required
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
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
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
Preferred
ASQ CQE certification preferred or ability to obtain within one year
Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred
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
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase