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Archiviertes Projekt - Systems Architect - Software as Medical Device

Firmenname für PREMIUM-Mitglieder sichtbar

Juni 2020

Mai 2021

CH-Basel

auf Anfrage

27.04.2020

CR/103154_1587981686

Projektbeschreibung

The Software as Medical Device team are looking for an experienced System Engineer / Software Architect. The candidate will contribute to the development of medical device and 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.

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 project teams 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
* Excellent problem-solving skills with an analytical mind



Requirements:

* Software and Medical device design using UML/SysML 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 the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).
* Experience with user experience, prototypes and proof of concept activities.
* Experience with cyber security, data privacy and system performance requirements.
* 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 project stakeholders to drive decisions

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