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Our Medical Technology client based in Warwick is seeking a Systems Engineer to lead the development and integration of dialysis products. You will ensure compliance with medical device regulations (IEC 60601, ISO 13485) while driving the feasibility, design, verification, and testing of system components.
Key Responsibilities:
- Develop and manage system-level requirements, documentation, and traceability throughout the product lifecycle.
- Lead Systems FMEA activities and identify system design improvements.
- Support prototype development, integration, and experimental testing.
- Drive integration, verification, and validation planning and execution.
- Analyze system performance, resolve issues, and propose solutions.
- Collaborate with cross-functional teams to define system architecture and improve engineering processes.
- Ensure compliance with risk management and regulatory standards (ISO 9001, ISO 13485).
Qualifications:
- Degree in Systems Engineering, Engineering, Science, or BioMedicine (Masters preferred).
- Experience with mechatronic/embedded systems and complex device development.
- Strong knowledge of the Systems Engineering V-model, from requirements through to testing.
- Familiarity with quality management systems and regulatory compliance (ISO 13485, ISO 9001).
- Excellent problem-solving, facilitation, and communication skills.
- Experience in the healthcare or other regulated industries is a plus.
Why Join?
- Lead the development of innovative, life-saving products.
- Work in a collaborative, dynamic environment.
- Make a meaningful impact in the healthcare industry.
