Staff Systems Engineer

Overview

Staff Systems Engineer responsible for technical content and quality management deliverables, field and manufacturing issue resolution, and system engineering deliverables for design change and maintenance/sustenance projects on medical device products.

What you'll do

• Be responsible for delivery of technical content and quality management deliverables.
• Provide oversight and guidance of resolution for field and manufacturing issues, including investigating to determine root causes, assessing risks, and determining appropriate CAPA actions.
• Work closely with technical teams to ensure fixes to field-reported issues are implemented after comprehensive impact analysis and evaluation.
• Mentor the Install base team on design strategies such as test for reliability, FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Action), and demonstrating compliance to various standards and processes.
• Act as primary author and reviewer of System Engineering deliverables required for design change and maintenance/sustenance projects.
• Work closely with support teams and interact with customers to continuously assess the performance of Portrait Mobile solutions product and track outcomes through established metrics.

What you'll need

• Bachelor's Degree in Computer Science or in STEM majors (Science, Technology, Engineering and Math).
• A minimum of 5 years of technical and professional experience in the Medical Device Industry in the capacity of systems engineer, development engineer, or verification lead.
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality and Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.
• Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives.
• Expertise in or understanding of Medical Device Software Design Principles, requirements for meeting various country regulatory clearances, and awareness of industry dynamics.
• Proven track record of successful problem definition, technical decomposition, and project estimation.
• Experience in at least one of the following product development activities: Verification/Validation, Defect management, CAPA, Compliant analysis and product surveillance in the medical device industry.

Nice to have

• Knowledge of software design principles, cybersecurity principles, cloud development, microservice architecture, distributed systems, multi-tenancy, orchestration, scalability, Web technologies enabled application development, and edge computing.
• Knowledge of technologies including Docker/Kubernetes, REST Web Services, architecture across SaaS/PaaS/IaaS, and cloud deployment.
• Experience in product development activities preferably in the Monitoring solutions domain.

Details

• Location: Bengaluru, India (IND19-01, EPIP 122 Phase II).
• Relocation assistance: not provided.