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Design Assurance Engineer in Kloten, Switzerland at Nobel Biocare

Date Posted: 11/28/2018

Job Snapshot

Job Description

Job ID: NOB002718

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.


Description

Main purpose is the remediation of technical files (i.e. triggered by Medical Device Regulations (MDR)) for the existing product portfolio.

The position holder should lift the risk management files to being MDR compliant, perform IFU updates (based on new risk or new technical file updates), review other development documentations from a quality point of view (test protocols, validation protocols, etc…) and ensure that all deliverables are established on time and in the required quality.  Furthermore she/he needs to ensure that the Design Risk Management process is followed and supports the management of standards and guidances.

The Design Assurance Engineer (MDR) is responsible to:

  • Provide technical documentation on time and in the required quality, in line with the General Safety and Performance Requirements specified within the MDR.
  • Act as an advisor to development team members to help them find a pragmatic way of achieving compliance.
  • Provide support for Quality and MDR compliance, including correcting quality problems in released products and compliance with the new regulations and standards
  • Participate in Design Review meetings and review Design Review documentations.
  • Perform Design Risk Management activities and ensure that data is updated or created to MDR standards.

Job Requirements



Qualifications

  • Higher education (preferably engineering or science)
  • 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.
  • Experience in interacting with project managers under pressure, in cross-functional work and a basic understanding of all functions in the company. Experience in Product Development and leading workshops.
  • 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 Technical project leader and withstand the tendency to skip necessary steps or do them unsufficiently. She/He must therefore be capable of working cross-functionally.
  • Fluent in English, German is a plus



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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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