Design Assurance Engineer in Kloten, Switzerland at Nobel Biocare

Date Posted: 6/9/2018

Job Snapshot

Job Description

Job ID: NOB002070

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


The position is supporting Product Develoment in different types of projects to ensure that all deliverables are established on time and in the required quality.  The incumbent is also reviewing the Engineering Change Orders to make sure that quality relevant aspects are covered. Furthermore she/he needs to ensure that the Design Risk Management process is followed and support the management of standards and guidances

The Design Assurance Engineer is responsible to:

  • Ensure a compliant execution of development projects by PD and Operations (in collaboration with the Site Quality Managers).

  • Ensure that Design Control relevant deliverables are established on time and in the required quality. 

  • Act as an advisor to development project members to help them find a pragmatic way of achieving compliance.

  • Ensure the proper handover of the projects from the development teams to the sites from a quality perspective (Design Transfer)

  • Approve / Review Change Requests and other technical documentation as described in the DC process

  • Participation in Design Review meetings and review of the Design Review documentations.

  • Review and support the Design Risk Management execution.

  • Support the onboarding of new suppliers in product lifecycle management projects.

  • Support to ensure the design transfer is performed according to the QMS regulation

Job Requirements


  • Higher
    education (preferably engineering or science)

  • At least
    2 years of experience in the Medical Device industry (preferably
    Development or Quality Management) and basic knowledge of ISO 13485, 21
    CFR 820, ISO 14971.

  • Consequent
    and efficient, compliant and pragmatic. The position will always be on the
    line to decide what is acceptable from a Quality Management perspective
    and what not. The position holder must be strong in discussion with the
    TPL (Technical project leader) and whitstand the tendency to skip
    necessary steps or do them unsufficiently. You should therefore be
    capable of working cross-functionally.

  • Experience
    from interacting with project managers under pressure, from
    cross-functional work and a basic understanding from all functions in the
    company. Experience in Product Development and leading workshops.

  • Experienced
    in effective and compliance design transfer of new products and
    technologies in production environment

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland.

For agencies: please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group