R&D Mechanical Engineer - Affluent Medical

R&D Mechanical Engineer

Responsible for planning, documenting, and executing design verification, and process validation studies for the design of implantable class III devices. The function also includes support for critical R&D Processes (Design control, Risk management, Process validations) as well as investigation responsibility of R&D assessment within NC-CAPA process. Contact person for the NiTi stent supplier technical management.


  • Setup, implementation and monitoring of in-vitro / benchtest testing protocols, including statistical assessment on a wide range of aspects, ranging from sample size definition and testmethod selection to analysis of-and reporting on the obtained data-sets
  • Support the interaction with supplier(s) of NiTi stent including NC-CAPAs, technical investigations, support incoming controls development, and technology transfer.
  • Support development of risk management file, process validations, and design control documentation.
  • Responsible person for Quality Engineering R&D support, including NC-CAPAs investigations, impact analysis on risk management file, and drafting of accompanying documentation.

R&D Director


Technical or Specific skills and Knowledges

  • Mechanical or Biomedical Engineer or similar
  • Knowledge of statistical methods for medical devices development.
  • Experience with NiTiNOL material properties, manufacturing process, and incoming inspection techniques.
  • Knowledge of design control, risk management, and NC-CAPA good practices.
  • Knowledge of statistical programming software: MiniTab.
  • Proficiency with languages (Italian, English)

Behavior skills

  • Open interaction within the R&D Team / team-player
  • Ability to work in an open and highly educated team
  • Solution oriented
  • Strongly objective oriented
  • Independent / autonomous
  • Availability to travel abroad Italy for a short period of time
  • Proactive mindset and selfstarting
Afin de postuler à cette offre, veuillez adresser votre candidature à jobopportunities@affluentmedical.com