System Engineer / Software Architect / no-527

Basel-Stadt, Basel  ‐ Vor Ort
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Beschreibung

For our customer located in Basel St. Johann/Switzerland we are currently looking for a: System Engineer / Software Architect (m/f/d)



The Packaging and Medical Device Development team at our client is looking for an experienced System Engineer / Software Architect to lead the technical development of smart delivery systems. The ideal candidate contributes to the development of complex 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 requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation.

Tasks & 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
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 with an analytical mind


Must Haves
Technical Skills:

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
Prior experience of integrating software modules developed by various team in the backend is highly desirable
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

Qualification

Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic 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 product development from concept to commercial launch
Experience in modern cloud architecture with IoT is a big plus
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 for both technical discussions with dev team and also for alignments with business stakeholders
Start
ab sofort
Dauer
12 Monate
(Verlängerung möglich)
Von
SimplyVision GmbH
Eingestellt
01.10.2020
Ansprechpartner:
Sourcing Team
Projekt-ID:
1976559
Vertragsart
Freiberuflich
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