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Job Details
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System Engineer - Basel - SaMD



Business Type: Medical Devices Company
Job Type: Medical Devices
Job Level: Experienced (non manager)
Position: Full Time
Location: Switzerland
Reference: DW.427874297879
Closing Date: 19/05/21
Job Details:

On behalf of one of the top 3 Pharma companies who are looking for a Systems Engineer, on a contract basis until at least the end of 2021 to be based in Basel. This is a chance to be a part of one of the largest pharmaceutical companies in the world, where extensions are expected allowing you to gain exposure with a reputable name and ultimately build further value for your profile. This is a contract with guaranteed working hours of 40 hours per week, paying 90CHF an hour.

The Connected Health Ecosystems & Operations team is looking for an experienced System Engineer to lead the technical development of connected delivery systems including a medical device, mobile phone app and cloud based data storage. The ideal candidate contributes to the development of complex medical devices and software as a medical device (SaMD) projects using state-of-the-art system engineering practices.


This highly interactive role will work with cross-functional teams to develop a platform architecture of reusable software modules that can be used across multiple products. This will include portfolio analysis of pain points and user needs, requirements elicitation and system modelling to define features and reusable components. They will write guidelines on how the system architecture is created, managed and tested at a platform level.

The primary responsibilities of System Engineer include:
* Design and implement systems 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 on defining pain points, user needs and technical design input requirements.
* Structure and visualise the system using systems modelling tools and integrate into a wider eco-system.

Technical Skills
* Systems and system of systems design using UML/SysML diagrams with good abstraction skills. Ability to decompose to device and software sub-systems. Domain modelling experience and linking to requirements definition and management a plus.
* Expertise in Web and Mobile application design, development and testing, as well as Cloud and IoT architecture and technologies for complex systems necessary, with application to SaMD.
* Detailed knowledge of using requirements management tools, previous experience of Polarion a plus.
* Prior experience of integrating and testing software modules developed by various teams is highly desirable.
* Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).

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 development, or other highly regulated industries
* Prior experience covering the medical device and/or SaMD product 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

Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstopconsulting.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a Contract professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.



Posted: 12/05/2021 | NPJ Ref: 270553
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