Altran is a global engineering consultancy and leader in R&D Services (ER&D), offering its clients a new way to innovate by developing products and services of tomorrow. Being a consultant for Altran means working alongside our clients on every link in the value chain of their project, from concept stage to industrialization. The Altran Group provides its expertise to key players in the Life Sciences sectors for Medical Devices-, Implants-, Laboratory Equipment Systems-, Biotech & Pharmaceuticals-, and Medical Device Apps.
Currently, we are looking for a
System Engineer / Software Architect
You would be creating products, tools and services that help enterprises manage their devices providing their employees with access to corporate applications, data and resources from virtually anywhere, on platforms such as Windows, iOS, Android and others, all while helping to keep corporate information and assets secure against known and emerging cyber threats meeting all the regulatory and compliance requirements.
You will contribute to the development of software as medical device (SaMD) projects using state-of-the-art system engineering practices.
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
Manage external vendors for development and lead the technical discussions with the vendors
Author relevant design history files and GMP compliant documentations.
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.
Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
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
Pharma experience is not mandatory. However work experience in medical device industry is highly desirable.
We are looking forward to receiving your application! We only accept applications through our online career portal. Applications via e-mail or 3rd party platforms will be deleted due to GDPR regulation. Your application may be considered for other open positions.