Our client is a leading innovator in the field of medical devices, dedicated to improving patient outcomes and enhancing healthcare delivery. The team are passionate professionals who are committed to developing cutting-edge solutions that make a difference in people's lives.
We are looking for a Systems Engineer to join their R&D team, who will play a crucial role in the design of their medical device. They will be responsible for creating the technology foundation that allows successful implementation of projects that meet regulatory standards.
Benefits
* 25 days' holiday pa, rising to 28, plus bank holidays
* Hybrid Working Arrangement
* Pension Scheme
* Bonus Scheme
* Life assurance
* Electric Car Benefit
Key Responsibilities
* Collaborate with cross-functional teams within the R&D department (Mechanical, Electronics, Software).
* Design and develop system architectures, components, and interfaces for medical devices, ensuring adherence to regulatory standards and industry best practices.
* Conduct system integration, testing, and validation activities to ensure the performance, reliability, and safety of medical devices throughout the development lifecycle.
* Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines.
Qualifications
* Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred.
* Proven experience in systems engineering within the medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines.
* Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation.
* Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.
* Experience with risk management processes and techniques applied to medical device development projects.
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