Samsung NeuroLogica

Full-stack Engineer

• Perform all phases of software development: requirements, design, implementation, verification, and release, including manufacturing testing and support
• Windows WPF and Unity development
• Implementation of advanced Unity concepts such as mobile, AR, VR, computer vision, etc.
• Assist in developing new, innovative product from the ground up
• Consider user experience implications and make recommendations for improvements
• Work closely within a small development team to troubleshoot development & production environments, performance tune, and optimize embedded systems
• Develop and execute test procedures
• Develop supporting design documentation
• Provide regular status reports, written and/or verbal, to cross-functional project team members
• Work individually with minimal supervision and as part of team of engineers
• Keep knowledge of all NeuroLogica products up-to-date
• Required to wear dosimeter when in direct contact with radiation emitting devices
• Operate mobile CRT scanner after training and follow all safety policies and procedures

Clinical Software Developer

Manager

• Manage daily QC operations including in process checks during manufacturing and final release of imaging systems
• Responsible for QC testing including (system and software) verification and validation for design changes and manufacturing improvement
• Investigate and document nonconformances, deviations, and product defects; lead root cause analysis and corrective actions
• Define, maintain, and improve QC documentation and processes to meet U.S. FDA 21 CFR 820 (FDA QMSR), MDSAP, EU MDR, ISO 14971 and ISO 13485 requirements
• Testing for sub-assemblies and system level testing for finished products
• External safety testing for changes at system level, critical components and end of life parts
• Generate appropriate metrics to quantify product quality including maintaining analysis of failing components, subassemblies and other issues
• Facilitate failure analysis and field defect analysis along with trending information
• Serve as a liaison providing quality engineering expertise for continuous process improvements for engineering, service and manufacturing personnel
• Review and verify product labeling
• Work with and respond to inquiries from regulatory agencies and assist with audits and inspections
• Contribute directly or manage designee to product ship reviews
• Direct the Incoming Inspection process of first articles, populated board assemblies and cable assemblies
• Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements
• Assist with initiatives in the quality department to meet corporate goals and ensure compliance with medical device regulations
• Assist with preparing field action documentation and executing the field action process
• Promote teamwork and collaboration within the quality function and with other functional areas
• Facilitate risk management activities (RMF, Risk/Benefit, planning, etc.) as needed for all products to ensure compliance with regulating bodies
• Create updates for Management Review Meeting and communicate clearly with company personnel, vendors, regulatory agencies, auditors and customers as required

Quality Control Manager

Supply Chain

• Lead all stockroom and logistics personnel, providing clear direction and support
• Recruit, interview, hire, and onboard management-level staff
• Manage, evaluate, train, and coach subordinates to ensure high performance and professional development
• Conduct timely and constructive performance evaluations
• Oversee daily departmental operations and ensure alignment with organizational goals
• Manage employee relations, including disciplinary actions and terminations, in accordance with company policies
• Represent Warehousing in all Manufacturing and Inventory meetings, articulating plans and updates to staff
• Manage all stockrooms, ensuring they are secure, organized, and inventory is accurate
• Control inventory levels and ensure availability of materials to support manufacturing and service requirements
• Manage daily cycle counting in all stockrooms utilizing the ERP system
• Keep detailed records of inventory transactions and update material shortages as needed
• Provide performance metrics and inventory reports as required
• Open and close Manufacturing Orders per the Master Production Schedule (MPS)
• Kit materials to support Manufacturing Orders in accordance with the MPS
• Responsible for all shipping, receiving, and logistics operations
• Administer logistics policies and standards governing the movement of goods and supplies
• Implement changes to improve efficiency and reduce costs associated with the logistics function
• Manage relationships with vendors and third-party logistics providers to ensure service quality and reliability
• Willingness to travel overnight as needed

Logistics and Inventory Manager

• Develop and maintain existing and future software systems ranging from embedded control systems, image processing, to complex user interfaces for the Company’s CT and other medical device products
• Perform all phases of software development: requirements, design, implementation, verification, and release, including manufacturing testing and support
• Develop C/C++ applications that utilize GPU processing techniques to hasten software throughput
• Troubleshoot development and production environments, performance tune, and optimize embedded/RT systems within a small development team
• Develop and execute test procedures and supporting design documentation
• Provide technical leadership in writing code, code architecture, peer reviewing code, and developing requirements and system architecture
• Provide regular written and verbal status reports to cross-functional project team members

Clinical Software Developer

Quality Control Manager

Logistics and Inventory Manager

Software Engineer, Image Reconstruction