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Lead Systems Engineer
2 months ago
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.
Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Roles and Responsibilities
- Be responsible for delivery of technical content and quality management deliverables.
- Work closely with technical teams to define design from high-level architecture, through technology selection and evaluation.
- Mentor design teams with design control process including requirements flow down, system design, design analysis, risk analysis, integration and test, verification and validation, manufacturing, field, FMEA (Failure Mode and Effects Analysis), and customer support including corrective and preventative actions to ensure customer satisfaction.
- Act as primary author and reviewer of system architecture, test design, design descriptions and customer documentation.
- Ensure that the solutions are timely in nature and through detailed comparative analysis of solutions options with global stake holders, solutions are scalable, sustainable, fault tolerant, and within operational cost budgets.
- Work closely with technical teams to manage technical program risks, design trade-offs, track technical program outcomes through established metrics
Required 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
- 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.
- 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 and cybersecurity principals
Good to have:
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.
Inclusions and Diversity:
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity .
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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