Job Detail

Company Description

We are Straumann.
United for global excellence in dentistry.

Every vision has its story. Ours began more than 60 years ago. Since then our innovations and achievements have become landmarks in dentistry worldwide. Straumann began as a family-owned institute, grew into a publicly owned holding, and today comprises a number of international companies around the world.

The Straumann Group develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics and biomaterials for use in tooth replacement and restoration solutions or to prevent tooth loss.

Job Description

We are looking for you as our Product Development Engineer SDIS (m/f). In this new role you will be part of an inspired and dynamic team, having the responsibility of working in the R&D MDR workstream to plan and execute R&D activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products comply with regulatory and compliance standards. Job responsibilities include addressing well-defined problems of limited scope and following standard practices and procedures. This opportunity will provide you a great basis to further advance your career in the medical device industry by gaining a solid understanding of this regulated industry, technical standards, planning and execution of device testing and technical documentation. This includes the following tasks: 

• Ensure validation and verification activities fulfillment within remediation projects timeline


• Technical support for remediation project team (Clinical and Regulatory department) within the scope of products assigned


• Define tests plan and ensure execution (ordering test samples, planning test, book equipment, perform testing)  


• Ensure that all product testing data (e.g. MRI, biocompatibility) is remediated or developed to MDR standards


• Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation


• Provides R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records

Qualifications

• Degree in mechanical engineering, bioengineering, or related field of study


• 1-3 years of experience in a related area such as development of medical device products


• Sound knowledge in applicable standards and regulations (MDD, FDA, ISO) and design control process


• Knowledge in the area of product development, manufacturing and testing, with specific development tools (e.g. FMEA, DoE, tolerance analysis, analysis of mechanical properties, statistical analysis)


• Previous experience in leading highly demanding product development projects is a plus


• Strong analytical skills and result orientation


• Distinctive interpersonal skills, customer focus and entrepreneurial thinking


• Effective and convincing communication, both verbally and in writing, fluent in English

Additional Information

INTERESTED?

We offer:

• Become part of a creative, inspired and engaged team as one of our #CangeMakers 


• Bring your ideas to life – create your footprint in the dental industry


• You can expect an informal, hand-on and international working environment with opportunities to grow

Florian Rupp, Global HR Business Partner RD&O, is your first contact for further questions you might have. Please apply via our online application system. For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.

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