Design Assurance Engineer: Risk & Usability Leader

Ultradent Products Inc; South Jordan (UT); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Ultradent Products Inc. seeks a personable and passionate Design Assurance Engineer to contribute to the development of medical device, drug, and cosmetic products.

You will join a team focused on safe, effective designs and regulatory compliance across markets. You will build expertise in Design Controls, Risk Management, and Usability Engineering, collaborating with R&D, QA, Regulatory, and Clinical Affairs to create verification, validation, and risk assessment plans that ensure safety and

Competenze

• Bachelor’s degree in engineering, science, or technical field (ideally).
• Understanding of Design Controls (21 CFR 820.30) and risk management.
• Strong communication skills and ability to interpret requirements.
• Ability to analyze complex information and apply industry standards.

Mansioni

• Develop subject matter expertise in Design Controls, Risk Management, and Usability Engineering.
• Collaborate with R&D, Product Development, QA, Regulatory, Clinical Affairs to cover design and evaluation.
• Create design verification/validation plans and guide test protocol development.
• Support Risk Management files and Usability Engineering documentation.

Conoscenze

Design Controls

Risk Management

Usability Engineering

Regulatory standards

Communication skills

Analytical thinking

Formazione

Bachelor's degree in engineering/science/technical field

Descrizione del lavoro

Ultradent Products Inc. seeks a personable and passionate Design Assurance Engineer to contribute to the development of medical device, drug, and cosmetic products.

You will join a team focused on safe, effective designs and regulatory compliance across markets. You will build expertise in Design Controls, Risk Management, and Usability Engineering, collaborating with R&D, QA, Regulatory, and Clinical Affairs to create verification, validation, and risk assessment plans that ensure safety and