Engineer III, Design Quality
About The Position
Provide quality support for ICU Medical Hardware and 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. 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
Requirements
- 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.
Nice To Haves
- ASQ CQE certification preferred or ability to obtain within one year.
- Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
