About this role

  • Location

    Switzerland

  • Salary

  • Type

    Contract

  • Division

    Medical Device Jobs

  • Reference

    LEA-0003-MD-CH

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Leanne Delaney

0203 865 5838

Leanne@xplorepharma.com

Description

I’m partnered with a Large Swiss Med Tech organisation, based in Zurich. They are looking for a R&D Engineer with the following skills to join their team for a 15 Month Contract.

 

Key responsibilities:

  • Responsible for identifying and closing gaps to meet European MDR (Medical Device Regulation) requirements as related to materials research areas
  • Developing and implementing materials testing and rationales to ensure safe and effective performance of products as well as optimizing and implementing of new and revised standards
  • Maintaining communication between vendors, suppliers, test laboratory engineers, outside consultants and outside researchers on matters pertaining to job duties and other business-related issues
  • Educating internal colleagues across departments and divisions
  • Supporting the project management activities, sourcing and supplier quality department in their material-related projects plus supplier interactions
  • Creating technical reports, test protocols and process descriptions as well as performing statistical data analysis
  • Monitoring and reviewing technical and medical literature

 

Experience

  • Bachelor, Master or PhD. degree in Engineering from an accredited curriculum in Materials, Chemical or Biomaterials Engineering or related discipline
  • 2 – 3 years R&D experience in medical device industry and related regulatory requirements (MDD/MDR, international standards)
  • Knowledge of metals, ceramic and/or polymer material and coating (e.g. hydroxyapatite, titanium) properties of medical devices, normative requirements and characterzation
  • Must have knowledge of material science. Physico-chemical properties of engineering materials and biomaterials are preferred
  • Familiar with substances requirements related to REACH / CLP / RoHs directives
  • Being confident with MDR requirements for permanent implants and surgical instruments, particularly materials related requirements
  • Well-known with materials characterization and biological evaluation per ISO 10993 (part 13, 14, 15, 18, 19, 22) and with risk management per ISO 14971
  • Experienced in writing technical protocols and reports as well as performing literature studies and statistical data analysis
  • Ability of analyzing all aspects of situation, identifying potential solutions and implement the best solution in a timely manner
  • Negotiating skills to effectively manage resources, timelines, problem solution and find compromises among different stakeholders
  • Strong oral and written communication skills in English and working knowledge of German
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