Sr. Medical Device Systems Engineer

• Systems Design and Development: Lead the design and development of systems within Medical Devices, ensuring they meet performance, safety, and regulatory requirements.
• Requirement Management: Define, document, and manage system requirements, ensuring alignment with customer needs, regulatory standards, and product specifications.
• Risk Management: Identify and assess risks associated with the Medical Device system, implementing strategies to mitigate them and ensuring compliance with risk management standards.
• Verification and Validation: Develop and execute verification and validation plans to ensure that the system functions as intended and complies with regulatory requirements.
• Integration: Oversee the integration of various components, subsystems, and software within the Medical Device, ensuring seamless functionality.
• Regulatory Compliance: Stay up to date with Medical Device regulations (e.g., FDA, ISO 13485) and ensure that the system design and development processes align with these regulations.
• Collaboration: Collaborate with multidisciplinary teams, including electrical engineers, software engineers, quality assurance, and regulatory affairs professionals, to achieve project goals.
• Documentation: Maintain comprehensive documentation of system design, development, and testing activities to support regulatory submissions and audits.
• Problem Solving: Troubleshoot and resolve technical issues related to system design and integration, ensuring that the device meets performance standards.
• Project Management: Manage project timelines, budgets, and resources effectively to ensure on-time and within-budget delivery of Medical Device Systems.

Requirements:

• Bachelor's degree in a relevant engineering discipline (e.g., biomedical engineering, electrical engineering, Systems Engineering)
• 3 years of experience in Systems Engineering, preferably in the Medical Device industry
• Software Application Development Experience within a cloud environment
• Design Control, CFR 820, ISO 13485
• Device History File generation and maintenance
• Software product development experience SDLC, 62304 standard compliances
• Verification and Validation
• Risk analysis, ISO 14975