Design Assurance Engineer

Nobel Biocare is an innovation leader in the field of implant-based dental restorations. We offer a dynamic and inclusive environment that fosters creativity and collaboration within our global workforce. We strive to provide the highest-quality implant solutions and workflows, enabling our customers to deliver optimal patient outcomes, while fostering practice growth. We embrace our position as a leader in the premium segment and uphold the highest standards in the dental industry. With a commitment to developing our talented workforce, Nobel Biocare is a great place to build your career. For more information about Nobel Biocare, visit www.nobelbiocare.com

Job Description:

The position is supporting Product Development in different type of projects to ensure that all deliverables are established on time and in the required quality.

The position holder is reviewing Design Control as well as Product Lifecycle related documents to ensure quality related aspects and compliance to internal procedures. Furthermore, the position holder ensures that the Risk Management Process is followed and supports the management of standards and guidances.

The Design Assurance EngineerNobel Biocare is responsible to:

• Ensure a compliant execution of new Product Development projects and Life Cycle Management activities including the review and approval of design control and change control relevant documents, in accordance with internal procedures and applicable regulatory requirements.

• Act as a consultant for the development teams / project team members to find pragmatic ways to achieve appropriate and compliant documentation of activities.

• Participate in change control activities (review and approval of change requests), in design review meetings and review of respective documentation.

• Support and review documents related to product, design and process risk management activities (and provide guidance).

Job Requirements:

Requirements:

• Higher education, bachelor or master degree in engineering or science.

• 2 Years of experience in the medical device industry or equivalent regulated industry (preferably in product development, quality management, risk management or manufacturing of medical devices).

• Basic understanding and knowledge on standards and regulation including but not limited to:
  - ISO 13485 - Medical devices - Quality management systems
  - ISO 14971 - Medical devices - Application of risk management to medical devices
  - 21 CFR 820 - US FDA Quality System Regulation
  - MDR - Medical Device Regulation 2017/745.

• Able to act consequent and efficient, compliant and pragmatic. The position is always on the line to decide what is acceptable from a Design Assurance and Quality Management perspective and what not.

• Strong in discussion with other stakeholders and withstand the tendency to skip necessary steps or do them insufficiently.

Operating Company:

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.