Design Assurance Engineer

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, 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 information.
• Drive 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.

Why work at Ultradent

Ultradent Products, Inc., is a collaborative and hard-working company with a 45-year history of innovation. Ours is a fun, fast-paced work environment dedicated to providing unique, solution-oriented products to dentists—and their patients—across the globe. Our company was built on a foundation of innovation, integrity, hard work, quality, and care, and we put those values into everything we do. We ask all colleagues to seek out the excluded, enhance the team, share feedback fearlessly, welcome feedback humbly, amplify all voices, and embrace our differences. Hear what some of our employees have to say #whyiultradent: https://youtu.be/UGpDHCaZ_Yw.

Benefits and Perks you’ll get at Ultradent

• Medical/Dental & Other Insurances (eligible the first of month after 60 days)
• Health Savings Account with employer contribution
• 401K Plan with employer matching contribution
• Employee access to discounted Ultradent products
• Excellent Paid Time Off (PTO) and Medical Time Off (MTO) account to support medical and military events
• Five days paid between Christmas and New Years
• Education Assistance
• Onsite Fitness Center