Engineer II, Design Quality
ICU Medical
full-time
Posted on:
Location Type: Hybrid
Location: San Clemente • California • United States
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Salary
💰 $71,250 - $102,125 per year
About the role
- Provide quality support for ICU Medical Hardware and Consumable development.
- Support activities such as CAPA investigations, design projects, and ensure compliance with quality system requirements.
- Utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc.
- Assure 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, and design transfers.
- Evaluate, prioritize, and mitigate potential product and process risks to improve quality.
- Support internal and/or external audits and inspections.
- Effectively interact with cross-functional team members.
- Provide quality support for on-market product issues, bringing issues to closure.
Requirements
- 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 2 - 4 years of experience in R&D and/or Quality is required.
- ASQ CQE certification preferred or ability to obtain within one year.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality supportCAPA investigationsdesign verificationrisk analysisproduct and process controlsvalidationdesign changestest readiness reviewsdesign transfersprocess risk mitigation
Soft skills
effective interactioncross-functional teamworkproblem-solvingcommunication
Certifications
Bachelor’s degree in engineeringASQ CQE certification