Design Assurance Engineer — Medical Devices (Risk & Usability)

Ultradent; Salt Lake City (UT); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Ultradent, Salt Lake City, UT, is seeking a Design Assurance Engineer to contribute to the development of medical devices and related products. The role emphasizes safety, effectiveness, and regulatory compliance across markets, with a focus on Design Controls and risk management.

You will become a subject matter expert in Design Controls, Risk Management, and Usability Engineering, collaborating with R&D, Clinical Affairs, QA, and Regulatory teams to ensure patient needs are met and quality

Qualifikationen

• Bachelor’s degree in an engineering, science, or technical field.
• Experience with medical device development is not required; any knowledge is an asset.
• Strong verbal and written communication skills.
• Ability to analyze and interpret complex information.
• Understanding of Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Usability Engineering (IEC 62366-1) and related guidance documents.

Aufgaben

• Develop subject matter expertise in Design Controls, Risk Management, and Usability Engineering.
• Collaborate with R&D, Product Development, Clinical Affairs, QA, Regulatory to ensure user and patient needs are met and regulatory coverage is maintained.
• Create design verification and design validation plans with SMEs.
• Participate in cross-functional activities such as risk assessments, test strategies, and test protocol development.
• Build and support Risk Management and Usability Engineering files.

Kenntnisse

Design Controls

Risk Management

Usability Engineering

Communication

Regulatory Knowledge

Ausbildung

Bachelor’s degree in engineering/science/technical field

Jobbeschreibung

Ultradent, Salt Lake City, UT, is seeking a Design Assurance Engineer to contribute to the development of medical devices and related products. The role emphasizes safety, effectiveness, and regulatory compliance across markets, with a focus on Design Controls and risk management.

You will become a subject matter expert in Design Controls, Risk Management, and Usability Engineering, collaborating with R&D, Clinical Affairs, QA, and Regulatory teams to ensure patient needs are met and quality