Job Description Summary

Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation.
Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results.
The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).

Job Description

In this role you will:

• Be responsible for delivery of technical content and quality management deliverables.
• Provide oversite and guidance of resolution for field and manufacturing issues that includes investigate to determine root causes, assessment of risks, and appropriate CAPA actions.
• Work closely with technical teams to ensure fixes to the field reported issues are implemented after comprehensive impact analysis and evaluation.
• Mentor the Install base team with design strategies like, test for reliability, FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive action) and demonstrating compliance to various standards and process.
• Act as primary author and reviewer of System Engineering deliverables required for Design change and Maintenance/Sustenance projects.
• Work closely with support teams interacting with customers to continuously assess the performance of Portrait Mobile solutions product and track outcomes through established metrics.Work closely with support teams interacting with customers to continuously assess the performance of Portrait Mobile solutions product and track outcomes through established metrics.Work closely with support teams interacting with customers to continuously assess the performance of Portrait Mobile solutions product and track outcomes through established metrics.

Basic Qualifications:

• Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math).
•  A minimum of 5 years of technical & professional experience in Medical Device Industry in the capacity of systems engineer/development engineer/Verification lead

Desired Characteristics:

Quality Specific Goals:

• 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 & 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

Technical Expertise:

• Expertise/understands Medical Device Software Design Principals, requirements for meeting various country regulatory clearances, and demonstrates awareness of industry dynamics.
• Proven track record of successful problem definition, technical decomposition, and project estimation.
• Knowledge of software design principals, cybersecurity principals, 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 at least one of the following product development activities: Verification/Validation, Defect management , CAPA, Compliant analysis and product surveillance in medical device industry, preferably in Monitoring solutions domain

Additional Information