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System Engineer / Software Architect (m/f)

For our client, a pharmaceutical company in Basel, we are looking for an experienced and ambitious System Engineer (m/f).

We are looking for an experienced System Engineer / Software Architect. The candidate will contribute to the development of software as medical device (SaMD) projects using state-of-the-art system engineering practices. This highly interactive role will work with cross-functional teams and support various development activities including system conceptualization, system requirement definition, risk assessment, system verification and clinical validation.

Main 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


• Excellent problem-solving skills

Technical skills

• Software and System design using UML diagrams with good abstraction skills


• Expertise in Web and Mobile application design, development and testing


• Experience with Cloud and IoT architecture and technologies for complex systems


• Knowledge of best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.)


• Experience with research, prototypes and PoC activities


• Experience with cyber security and performance requirement

General information

• Start date: 01.06.2020


• End date: 31.05.2021 - Extension possible


• Location: Basel


• Workload: 100%

Must-Have

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


• Minimal 5 years of experience in medical device, or other highly regulated industry 


• Prior experience covering the medical device or SaMD development from concept to commercial launch


• Experience working with the requirements and traceability management tools 


• Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304) 


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

  

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

Contact

Nadine PapaTalent Acquisition Consultant+41 61 500 01 78nadine.papa@datalynx.ch Find more vacancy at: www.datalynx.comJetzt bewerben