Research Engineer Biomechanics MDR (2 years contract)-NOB002775
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single tooth to fully edentulous indications. We offer dental implant systems, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. We support customers throughout their professional and practice development. Our headquarter is in Zurich, Switzerland, and we have around 34 direct sales organizations worldwide. Nobel Biocare is a member of the Danaher Corporation, a diversified technology leader.
For the implementation of the Medical Device Regulation (MDR) by 2020 the Biomechanics team at Nobel Biocare is searching for a subject matter expert to support the creation of the documentation related to mechanical safety and efficacy for all Products and solutions. The Research Engineer will be responsible for the detection of gaps in the current documentation and creation of evidence (through mechanical testing or rationalization and argumentation) for safe and effective performance for the discovered gaps.
• Gap analysis of current product documentation and definition of action plans and strategies to lift technical documentation to compliance with the MDR
• Definition of strategies and actions for providing evidence for the existing gaps.
The defined strategies need to be in alignment with other subject matter experts and ideally allow simplified/sustainable product life cycle management in in the future
• Organize and/or execute (where performed internally) the mechanical testing activities for missing evidence. Alternatively, document rationales and argumentation in technical reports.
• Document activities in technical reports and summarize in verification reports for update of the technical documentation.
• Degree in biomechanical or mechanical engineering
• Proven documentation skills in English
• Technical analysis of existing data and definition of gaps
• Definition of strategies for gap closure
• skilled in technical documentation (English)
• strategic thinking for the alignment of the created documentation across departments and in order to allow simpler/sustainable product life cycle management in future
• minimally 2 years of professional experience as (bio-)mechanical engineer, PMS specialist, or equivalent
• Experienced to work in regulated environment, preferably Medical Devices
• Experienced with medical device clearance processes is a plus
• Knowledge of product life cycle management of medical devices (e.g. Post Market surveillance (PMS), complaint management, etc.) is a plus
• High affinity to quality and quality management
• Thinking outside of the box, to define strategies and approaches for gap closure
• Timely delivery of documentation
• Cross-functional alignment with other subject matter experts (find evidence where own expertise is insufficient)
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