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Systems Engineer - Medical Devices, Trowbridge
Client:
Cpl
Location:
Trowbridge, United Kingdom
Job Category:
Other
EU work permit required: Yes
Job Reference:
b7a926b839f8
Job Views:
3
Posted:
26.04.2025
Expiry Date:
10.06.2025
Job Description:
Our client, a Medical Device Manufacturer, is seeking an experienced Systems Engineer to lead engineering insights and develop solutions for existing and new products. The role involves overseeing investigation and development activities, planning and evaluating network technologies, and providing device integration engineering services, including technical investigations and problem-solving.
The Systems Engineer will also lead quality improvement activities and propose innovative solutions to technical challenges.
Responsibilities include:
* Maintaining technical oversight of the io platform and cartridges, including firmware, software, and interfaces.
* Providing system-level technical expertise to align hardware and component teams.
* Assessing and improving system architecture.
* Maintaining the instrument Design History File (DHF).
* Planning and leading new hardware development for the io and cartridge platform.
* Defining verification scope and supporting validation activities.
* Preparing regulatory submission documents.
* Investigating and developing solutions for platform improvements.
* Monitoring platform reliability and performance.
* Steering software development requirements.
* Supporting security management, including risk and vulnerability analysis.
* Collaborating with R&D to streamline processes and innovate.
* Troubleshooting faults, leading root cause analysis, and planning remedial actions.
Qualifications and Skills:
* Bachelor's degree in Clinical Engineering, Biomedical Engineering, Systems Engineering, or related field.
* Minimum 5 years' experience in healthcare or molecular engineering, with familiarity with FDA QSR and ISO standards.
* Experience in IVD diagnostic product development, including statistical experimental design.
* Strong understanding of mechanical, electronic, and software design principles.
* Basic knowledge of molecular biology, especially PCR and sample prep.
* Proven project and personnel management skills.
* Ability to diagnose and resolve complex technical/system issues.
* Knowledge of electronic, mechanical, and computer reengineering principles.
* Understanding of clinical systems architecture for medical device interoperability.
* Proficient in computer literacy, including word processing, spreadsheets, databases, graphics, statistics, engineering tools, and programming.
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