Job Detail

TEMP Research Senior Engineer 100% m/f (until December 2022)

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Requisition Number

EMEA07522

Employment Type

Full-time

Location

Winterthur

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

For the Swiss Manufacturing Plant, based in Winterthur (Switzerland), we are looking for a:

TEMP Research Senior Engineer 100% m/f (until December 2022)

Job Summary

The TEMP Research Senior Engineer supports the implementation of the new EU MDR (European Union Medical Device Regulation) requirements related to the cleanliness, sterilization and biocompatibility of orthopaedic implants and surgical instruments. Responsibilities include the biological safety assessment of materials and devices to meet the EU MDR requirements. He or she will work in a matrix and cross functional environment and will be responsible for acting as a primary liaison in the communication between Research, Development, Quality, Regulatory Affairs and Operations across different sites overseeing all relevant standards, updating related processes, documents and specifications related to the implementation of the MDR requirements in research and biocompatibility related areas.

Your main responsibilities

• Create and updating technical reviews, specifications and other documents for regulatory submission


• Interpret technical drawings, biological assessments and biocompatibility data


• Review and validate reusable device cleaning and sterilization


• Coordinate biocompatibility testing with internal and external laboratories


• Perform toxicological and/or microbiological assessment of materials and devices


• Create, revise and review procedures and documents required for MDR compliance


• Write benefit-risk analyses, test protocols and reports


• Closely communicate with internal and external consultants, and cross-functional project teams worldwide, i.e. Research, Quality, Supplier Quality, Regulatory, and Manufacturing
  
  

Your Qualifications and Experience

• Minimum education requirement is a MSc degree in relevant scientific disciplines, such as microbiology, toxicology, biology, or chemistry (preferred is a PhD degree)


• An advanced degree or experience in the field of medical device safety (e.g. biocompatibility or industrial sterilization) is a plus


• Basic knowledge of industry standards and regulations, especially EU MDR and ISO 10993


• Understanding of the principles and requirements of current Good Manufacturing Practice (cGMP) is an advantage


• Coordinating and completing projects with challenging time lines


• Fluent in English (written and spoken); working knowledge of German is an advantage


• Demonstrates strong written and verbal communication skills


• Ability to integrate and interact efficiently in a team


• Ability to work meticulously on written documents


• Demonstrates ability to utilize resources efficiently
  
  

Travel Requirements

Willingness to travel up to 5%

If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team. Zimmer Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application online.

 

Zimmer Switzerland Manufacturing GmbH

Herr Adrian Witschi
Human Resources Business Partner
Sulzerallee 8                                      
8404 Winterthur                                 
www.zimmerbiomet.com

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