Project Leader and DV Engineer

Main Tasks:

·       Lead projects of low complexity for the development/optimization of components/finished products for the blood purification of patients suffering from chronic or acute kidney failure (e.g. hemodialysis or peritoneal dialysis) including further blood purification treatments (e.g. apheresis) as assigned by the supervisor

·       Coordinates the technical aspects and activities related to implementation in production of new products (bill of materials, verification of availability of proper components, verification of supplier capacity, discussion with production department to verify feasibility).

·       Define and document medical device design, development and changes according to internal procedures, Design Control requirements and reference standards.

·       Define and update project requirements and input for the respective product group

·       Defines and updates design output (e.g. technical specifications of the components and finished product)

·       Provide support for the FMEA/Risk Analysis update and for the preparation of the technical documentation for the activities related to the project

·       Lead, coordinate and execute Design Verification and Validation tasks in projects (e.g. preparation and release of design verification documentation: Design Verification Plan, Protocol and Report) according to referenced standards and internal procedures

·       Collect and analyze information (raw data or report) from the involved teams and finalize design verification and validation documentation project documents

·       Develop Test Methods for Design Verification and perform Test Method Validation

·       Support Product Interface documentation release acting as Product Interface Manager

·       Lead and support Design Transfer activities

·       Work closely in Cross Functional Team with both internal groups (Product Development, regulatory, Manufacturing and Marketing) and external groups (Clinicians, Consultants, Regulatory)

·   Support to Production for technical problems

·   Support to Plant Quality Control (definition of corrective/preventive actions)

Qualifications, experience, know-how and skills

1) Required training, professional registration and education:

University Degree or similar education level in bio-engineering/mechanical engineering discipline.

2) Required professional experience:

2 years in Project Leader or Design Verification Engineer role (desirable)

3) Required personal competencies:

·   Open mind approach,

·   Team Leadership,

·   Project/activity organization/management ability

4) Other specialized knowledge, expertise and skills:

·   Technical management of projects

·   Statistics (basics)

·   Basic understanding of 3D CAD modelling principles and techniques, basic experience in CAD modelling, knowledge of 2D constructive mechanical drawing

·   Knowledge about plastic materials and relative processing technologies (processing, assembly, sterilization)

·   Good spoken and written English (e.g. CET-4)

·   Minitab

·   Very good command of Microsoft Office suite (Excel, Power Point, Project, Visio, Word)

·   SAP (basic knowledge)

·   Basic knowledge about therapies

·   Deep technical knowledge about requirements and characteristics for disposable non-active Medical Device design, development and manufacturing.