Engineer III, Design Quality

ICU Medical • Salt Lake City, UT

417d

About The Position

The Engineer III, Design Quality position at ICU Medical focuses on providing quality support for hardware and consumable development. The role involves ensuring compliance with quality system requirements and applicable regulations, conducting CAPA investigations, and participating in design projects to assure product quality.

Requirements

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university.
• Minimum of 4 years of experience in R&D and/or Quality.
• Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System.
• Knowledge of medical device standards, ISO 13485, MDSAP, EU MDR, and ISO 14971.
• Knowledge in Statistics and Minitab is preferred.

Nice To Haves

• ASQ CQE certification preferred or ability to obtain within one year.

Responsibilities

• Utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, and design verification to assure product quality.
• Ensure compliance with FDA regulations and international regulatory agencies.
• Provide compliance guidance related to quality standards in product development.
• Ensure all quality attributes for design changes are met.
• Participate in design reviews, test readiness reviews, and cross-functional teams.
• Evaluate, prioritize, and mitigate potential product and process risks to improve product quality.
• Support internal and external audits and inspections.
• Maintain Design History Files (DHF) as needed.
• Interact effectively with cross-functional team members.
• Provide quality support for on-market product issues and escalate to management as necessary.
• Work on special projects as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree