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Sr. Medical Device Systems Engineer

1 month ago

Addison, United States Katalyst HealthCares and Life Sciences Full time
Job Description Responsibilities:
  • 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