R&D Technical Leader – Medical Devices
Kennziffer der Stelle
Operations — Engineering
1 bis 3 Jahre
Modena, Emilia Romagna, Italien
Akkodis is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC.
Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics.
The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is a commercial brand under which both AKKA and Modis entities operate.
With a view to strengthening our team, we are looking for a:
R&D Technical Leader - Medical Devices
The resource will operate in R&D within the Medical Devices Business Unit and will be responsible of the design of components and finished products.
The main tasks will be:
- Support and management for creation of drawings and bill of materials for components and finished products
- Definition and implementation of functional physical tests of the products under development
- Drafting of the product design documentation (design input, design output, design transfer)
- Assistance to Production in the development of new projects or sustaining of products already on the market
- Participation in activities related to change control and investigation of complaints
- Collaborate cross functionally leading R&D activities /projects
- Responsible for Risk Analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA
- Investigate and respond to complaints
- Technical review Clinical Evaluation Report CER
- Responsible for analyze Post-market surveillance report
The ideal candidate has a Degree in Biomedical Engineering (or similar) and at least 3 years of experience in the role. Geographical mobility is required at national and international level. Knowledge of the English language is required.
- Product Life Cycle system and Design Control knowledge
- Project Leading skills
- Knowledge of FDA QSR, ISO13485, ISO 8637-1, ISO14971 and EU Medical Device Directive
- Plastics material know how and process technique as injection molding
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OPERATIONS — Engineering
OPERATIONS — Engineering
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