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System Engineer (m/f)

For our client, a well-known pharmaceutical company based in Basel, we are hiring an experienced System Engineer  (m/f).

Job description

The System Engineer will contribute to the development of best-in-class system engineering practices and its implementation to medical device and/or software as medical device (SaMD) development projects. The preferred candidate has practical experience covering the product development to the life cycle management. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation. 

General Information

• Start Date: ASAP


• Duration: one year duration


• Work location: Basel


• Work load: 100%


• Remote: not possible

Responsibilities

• Design and implement system engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies, and SaMD. 


• Demonstrate strong technical know-how at system level and guide the development team to use structured system engineering approach for product development 


• Utilize the system engineering tool for requirement management and translate user and business needs into system/sub-system requirements 


• Actively maintain and monitor the traceability from the requirements to the verification activities 


• Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders 


• Manage external vendors for development and lead the technical discussions with the vendors 


• Author relevant design history files and GMP compliant documentations 

Qualifications

• 6+ years of experience in network architecture


• 5+ years of experience in system design


• Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines 


• Track record of going through the product development cycle, from prototype to commercial launch, in the medical device industry or GMP environment is highly valued


• Good knowledge in systems engineering approach and risk-based approach for product development 


• Experience working with the requirements and traceability management tools 


• Knowledge in system functional modeling and/or programming ability using system modeling language (SysML) will be a plus. 


• Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantage 


• A good team player, and problem solver with strong analytical mind 


• Strong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions

Must-Haves

• Understanding of medical device standard/regulations (ISO13485, 21 CFR part 820, IEC 62304)


• Practical experience working in Medtech industry


• Strong technical expertise in one of the engineering fields or technical areas mentioned above in JD

 

 

We are able to offer you diversified responsibilities in a professional and dynamic international team, performance-matched benefits, and a friendly work environment.
 
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We look forward to receiving your online application with your CV.
 
For any questions please do not hesitate to contact us.

Contact

Valbona KrasniqiAdministrative Assistant+41 61 500 01 77valbona.krasniqi@datalynx.ch  www.datalynx.comJetzt bewerben