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.
DESCRIPTION DE POSTE
DESCRIPTION DES PRINCIPALES ACTIVITÉS
- 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.
RATTACHEMENT HIERARCHIQUE MANAGER
R&D Director
COMPETENCES REQUISES
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
CANDIDATURE
Afin de postuler à cette offre, veuillez adresser votre candidature à jobopportunities@affluentmedical.com