Advanced Systems Architect
5 days ago
Job Opportunity: Lead Complex Medical Device Systems Engineering
About the RoleWe are seeking an accomplished Senior Systems Engineer to oversee our systems engineering efforts across the development of intricate medical devices.
Key Responsibilities- Provide authoritative leadership in design activities, encompassing risk management, technical investigations, requirements analysis, system architecture, detailed design, integration, testing, verification, and validation tasks.
- Lead verification activities and provide comprehensive documentation to support regulatory submissions for our existing products.
- Offer strategic guidance with the integration activities on company projects.
- Maintain thorough documentation of design and development processes, including specifications, test plans, and reports to ensure traceability and accountability in the product development lifecycle.
- Bachelor's degree in biomedical engineering, systems engineering, or a related field.
- 10+ years of experience in systems engineering for medical devices.
- Experience in the design and development of medical devices, preferably Class II or III.
- Strong knowledge of embedded systems, electronics, optics, and electro-mechanical systems.
- Knowledge of international standards relevant to medical device development.
We are a global leader in microscopic imaging, with patented technologies enabling in vivo imaging of tissues across a wide range of surgical, pathology, and life sciences applications. We are expanding our portfolio and will transform patients' lives by enabling digital biopsies for cancer screening, diagnosis, and treatment.
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