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Hobson Prior are currently recruiting for an experienced System Engineer to lead the technical development of connected delivery systems. You will join Swiss world-wide pharmaceutical company based in Basel on a contract basis.
- To 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.
- 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.
- Write, implement, and report on integrated system design verification and validation activities, especially in end-to-end software testing.
- Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders.
- Author relevant design history files and GMP compliant documentations.
- Excellent problem-solving skills with an analytical mind.
- Strong communication skills for both technical discussions with dev team and for alignments with business stakeholders.
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines.
- At least 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).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€55 - €75 per hour
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