Systems Engineer - Basel - Remote
On behalf of one of the top Pharmaceutical Companies, we are looking for a System Engineer, on a contract basis for at least 6 months to work remotely. 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.
We are 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 and support various development activities including requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation.
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 visualize the system using systems modelling tools and integrate into a wider eco-system.
- Utilize the system engineering tool for requirements 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
- Implement risk management at systems level and co-ordinate risk management activities at component level.
- Author relevant design history files and GMP compliant documentations.
- 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
- 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
- Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
- 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.
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