Role Summary / Purpose :
As a Lead Systems Designer in CCS Data and Analytics team, you will lead a small to mid-sized cross-functional program team to deliver the technical content, performance, intellectual property and quality deliverables of NPI programs.
Essential Responsibilities :
Ensure that the quality targets are satisfied and retires technical risks as they arise on the program
Lead the design team and design control process from requirements development and design planning to design transfer
Lead the design team in the development of verification and validation planning and execution.
Develop requirements flow down, architecture / system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
This also includes architecting periodic Usability assessment with customers.
Drive the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, reliability, serviceability and quality
Drive strategy to improve design and development process that includes adopting automation and increasing
collaboration between teams
Coach and mentor junior engineers
Quality Specific Goals :
1. Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality
Goals, and applicable laws and regulations as they apply to this job type / position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure compliance / closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI
5. Lead continuous improvement activities by driving the implementation of process and product quality Summary / Purpose :
Bachelor's Degree in Computer Science or in - STEM- Majors (Science, Technology, Engineering and Math)
A minimum of 10+ years of professional experience
A minimum of 5 years of experience as a development engineer in medical software domain
Demonstrated experience driving CTQ flow-down to subsystems
Demonstrated ability to work with technical leadership team to implement product platform / subsystem multi-
generation technology plan for a specific release of a global program / product
Exposure to Systems design and technical depth in one or more engineering disciplines
Desired Characteristics :
Demonstrated experience with NPI and regulatory compliance process, design history file and collaterals are in place and current
Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks / issues
Demonstrated skills in proactively identifying, facilitating and driving closure of a product / program
Strong interpersonal skills and communication (written and spoken) skills.
Demonstrated skills in proactively identifying, facilitating and driving closure of a : +91 98 1845 4080 / 98 6860 9864
ref : hirist.com)