Drive technical excellence and quality assurance within systems engineering. This role is crucial for developing and optimizing complex systems, encompassing both customer business needs and technical requirements. You will be instrumental in the design, creation, and continuous improvement of systems throughout their lifecycle, from concept to operation.

The position involves leading departmental planning and execution or focusing on specialized technical activities. While operating with a degree of autonomy, guidance will be provided through established policies, ensuring work meets high standards of quality, volume, and timeliness. Opportunities exist to refine procedures and practices to achieve these outcomes.

Key responsibilities include delivering high-quality technical content and quality management artifacts. You will guide the resolution of field and manufacturing issues, investigating root causes, assessing risks, and implementing CAPA actions.

Collaborate closely with technical teams to ensure effective implementation of fixes for reported issues following thorough impact analysis. Mentor the Install Base team on design strategies such as reliability testing, FMEA, CAPA, and compliance with relevant standards.

Serve as the primary author and reviewer for System Engineering deliverables essential for design changes and maintenance projects. Engage with support teams and customers to continuously evaluate product performance, tracking outcomes via established metrics.

A Bachelor’s Degree in Computer Science or a STEM field is required, coupled with a minimum of 5 years of professional experience as a Systems Engineer, Development Engineer, or Verification Lead within the Medical Device Industry.

Desired expertise includes a strong understanding of Medical Device Software Design principles, regulatory clearance requirements, and industry dynamics. You should possess a proven ability in problem definition, technical decomposition, and project estimation.

Familiarity with software design principles, cybersecurity, cloud development, microservices, distributed systems, and scalability is essential. Experience with technologies such as Docker/Kubernetes, REST Web Services, SaaS/PaaS/IaaS architectures, and cloud deployment is highly valued. Prior involvement in Verification/Validation, Defect Management, CAPA, complaint analysis, or product surveillance within the medical device sector is particularly beneficial.