Global Head of Engineering / Manufacturing (Medical Devices)
Our client, a Medical Device Manufacturer, is currently looking to appoint an experienced Systems Engineer who will lead engineering technical insight within the business and develop engineering solutions for the existing product range or for new products. Additionally, the Systems Engineer will drive and oversee investigation and development activities from an engineering perspective.
This person will plan and evaluate network technologies to enable, enhance, and support connectivity and integration. This role will provide device integration engineering services to research areas including selection, acquisition and service, technical investigations, and clinical/technical problem-solving.
They will also lead quality improvement activities and suggest innovative solutions to technical problems.
Responsibilities of the Systems Engineer:
1. Maintain an overview of all technical aspects of the io platform and cartridges including firmware, software, and system cartridge interfaces.
2. Provide technical expertise at the system level to align technical teams on hardware and supply components.
3. Assess existing system architecture and recommend improvements and enhancements.
4. Maintain the instrument DHF.
5. Plan and lead new hardware developments and a pipeline for the io and cartridge platform.
6. Define the scope of verification testing and provide key support for verification and validation activities. Complete testing protocol and analyze reports.
7. Prepare documents for and support regulatory submissions.
8. Investigate and develop solutions and new opportunities in the io and cartridge platform.
9. Monitor reliability and performance in the io platform.
10. Steer requirements for software developments on the io platform.
11. Support security management processes including risk and vulnerability analysis and related documentation associated with interconnected and integrated devices and systems.
12. Interface with the R&D team to bring solutions to new and existing products including streamlining current processes and idea invention.
13. Troubleshoot and investigate errors and faults, lead root cause analysis and plan remedial actions.
Education, Experience and Demonstrated Skills:
1. Bachelor's degree in Clinical Engineering, Biomedical Engineering, Systems Engineering or related engineering field.
2. At least 5 years’ experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485.
3. Experience developing products in IVD diagnostic development, including use of statistics in experimental design.
4. Strong understanding of mechanical, electronic, and software design principles.
5. General understanding of molecular biology, focused on PCR and sample preparation.
6. Strong skills in management of engineering projects and/or personnel.
7. Ability to diagnose and solve technical and/or system problems of a high degree of complexity.
8. Knowledge of electronic, mechanical, and/or computer reengineering design and applications principles.
9. Knowledge of clinical systems architecture used for medical device interoperability.
10. Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools, and programming.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Medical Equipment Manufacturing
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