Danaher Corporation Design Assurance Engineer in Kloten, Switzerland
Danaher Company Description
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 Development 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 guidance
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 documentation.
- 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
* 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 withstand the tendency to skip necessary steps or do them insufficiently. 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 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.
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002665