Senior Systems Engineer
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Role details
Tech stack
Job description
- Translate stakeholder and clinical needs into system and subsystem requirements.
- Develop system architecture, functional decomposition, interfaces, and technical specifications.
- Maintain requirements traceability and manage technical risks.
- Lead system integration, prototype bring-up, and performance characterization.
- Conduct risk assessments, including PHA, FMEA, and DFMEA.
- Develop verification strategies, test plans, protocols, and acceptance criteria.
- Support Design History File documentation, regulatory deliverables, and design transfer.
- Collaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams.
Requirements
Systems Engineering, Electrical Engineering, Systems Engineering, Radiation Therapy, System Architecture, Manufacturing, System Integration (SI), Clinical Information Systems, Functional Decomposition, Traceability, * Complex electromechanical product development.
- System architecture, requirements management, integration, verification, and validation.
- Knowledge of ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366-1.
Preferred Experience: Medical devices, radiation therapy systems, medical linear accelerators (LINACs), imaging systems, or robotics.
Benefits & conditions
Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements: Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums. Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO other than that required by applicable state and local laws
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