Design Assurance Engineer

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, the global name in oral health is seeking a personable and passionate Design Assurance Engineer to contribute to the development of medical device, drug, and cosmetic products. You would be a member of a team of Design Assurance Engineers who work closely with multidisciplinary project teams to develop products in ways that are—above anything—safe and effective for the users and patients, but also that meet the regulatory requirements for entry into numerous markets and that meet the needs of the company.

As a Design Assurance Engineer, you would become a subject matter expert in Design Controls, Risk Management, Usability Engineering, product-specific standards, and the pragmatic application of these tools within development projects. This role is people-oriented, often involved in establishing higher-level development strategy, and is less hands-on than many other engineering roles.

As part of this team, you would be immersed in the following:

• Developing subject matter expertise in Design Controls (21 CFR 820.30), Risk Management (ISO 14971), and industry-specific regulations, standards, and guidance documents.
• Building relationships and working directly with Research and Development, Product Development, Clinical Affairs, Quality Assurance, Regulatory Affairs, among others, to make sure user and patient needs are met and that quality and regulatory considerations are covered in the design and evaluation of products.
• Communicating with subject matter experts to create design verification and design validation plans.
• Participating in cross-functional activities such as creating and reviewing design inputs, conducting risk assessments, developing test strategies, and guiding test protocol and method development.
• Building and supporting Risk Management and Usability Engineering files.

What you’ll need to succeed:

• Bachelor’s degree in an engineering, science, or technical field is ideal

What we’re looking for in you:

• Experience with medical device development process is not required; any previous experience or knowledge of the topic would be an asset
• Understanding of engineering principles and best practices
• Strong communication skills both verbal and written
• Ability to analyze and interpret complex informationDrive to understand and apply requirements found in Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Usability engineering (IEC 62366-1) and other industry regulations, standards, and guidance documents

Ultradent is an Equal Opportunity Employer. We are a global culture where differences and perspectives are sought after, welcomed, and embraced. We consider all qualified applicants fairly, based on their experience, skills, and potential to contribute to our team. Our core values – Integrity, care, quality, innovation, and hard work- guide us daily. These values, when balanced, shape our workplace culture and ensure that we remain focused on our vision while maintaining a professional and inclusive environment.
VEVRAA Federal Contractor: For more information please contact us at [e-mail]

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