Sr. Medical Device Systems Engineer - Katalyst Healthcares & Life Sciences
Dallas, TX 75001
About the Job
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.
- 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
Source : Katalyst Healthcares & Life Sciences