Design Assurance Engineer - Medical Devices & Risk

Ultradent Products Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Insurance

HSA with employer contribution

401K with employer match

Paid Time Off

Education Assistance

Onsite Fitness Center

Job summary

Ultradent Products, Inc. is seeking a personable Design Assurance Engineer to contribute to the development of medical devices, drugs, and cosmetics, ensuring safety, effectiveness, and regulatory compliance for market entry across multiple regions.

You will collaborate with R&D, Product Development, Clinical Affairs, QA, and Regulatory teams to implement Design Controls, risk management, and usability engineering throughout product lifecycles, while building SME status and guiding

Qualifications

• Bachelor’s degree in engineering, science, or technical field required or preferred.
• Strong communication skills, both verbal and written.
• Ability to analyze and interpret complex information; applies to regulatory guidance.

Responsibilities

• Develop expertise in Design Controls (21 CFR 820.30), ISO 14971, and IEC 62366-1.
• Collaborate with R&D, Product Development, Clinical Affairs, QA, and Regulatory teams.
• Create design verification and design validation plans; guide test protocol development.

Skills

Design Controls

Risk Management

Usability Engineering

Communication skills

Regulatory knowledge

Education

Bachelor's degree in engineering or technical field

Job description

Ultradent Products, Inc. is seeking a personable Design Assurance Engineer to contribute to the development of medical devices, drugs, and cosmetics, ensuring safety, effectiveness, and regulatory compliance for market entry across multiple regions.

You will collaborate with R&D, Product Development, Clinical Affairs, QA, and Regulatory teams to implement Design Controls, risk management, and usability engineering throughout product lifecycles, while building SME status and guiding