Design Assurance Engineer: Risk, Usability & Compliance

Ultradent Products, Inc.; Salt Lake City (UT); On-site; USD 95,000 - 140,000; Full time

Job summary

Ultradent Products, Inc. seeks a Design Assurance Engineer to advance medical device, drug, and cosmetic products with a focus on safety and regulatory compliance.

You will work within a team to ensure quality and patient needs are met while applying Design Controls, Risk Management, and Usability Engineering across development projects. You will engage with R&D, Clinical Affairs, QA, Regulatory, and other functions to create verification/validation plans and guide test strategy.

Qualifications

• Bachelor’s degree in an engineering, science, or technical field is ideal.
• Strong knowledge of design controls, risk management and usability engineering.
• Ability to communicate clearly with cross-functional teams.

Responsibilities

• Develop design verification and design validation plans with SMEs.
• Collaborate with R&D, Product Development, QA, and Regulatory to address user needs.
• Support risk management and usability files throughout the project lifecycle.
• Translate regulatory requirements into design considerations and documentation.

Skills

Design Controls (21 CFR 820.30)

Risk Management (ISO 14971)

Usability Engineering (IEC 62366-1)

Communication skills

Analytical interpretation of complex信息

Education

Bachelor’s degree in engineering/science/technical field

Job description

Ultradent Products, Inc. seeks a Design Assurance Engineer to advance medical device, drug, and cosmetic products with a focus on safety and regulatory compliance.

You will work within a team to ensure quality and patient needs are met while applying Design Controls, Risk Management, and Usability Engineering across development projects. You will engage with R&D, Clinical Affairs, QA, Regulatory, and other functions to create verification/validation plans and guide test strategy.