This position will support the software architecture, design, development and testing efforts associated with vascular navigation platform development. In addition, this position will be key in sustaining efforts in support of the currently released navigation platforms.
The successful candidate will ensure the requirements of Quality Assurance and Regulatory Compliance programs are met for the projects under development.
- Software development including architecture design, code development, prototyping, test method development and testing (verification and validation) risk management and documentation.
- Technical leadership of selected projects and activities. Track and communicate developments from prototype design through testing and into production. Actively support both agile and waterfall methodologies. Formulate technical trade-offs analysis to facilitate business decisions for expeditious project advancement.
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.
- Identify and create new design and/or process concepts. Stay current with cutting-edge software methods and tools for medical device industry and technology trends, ensuring innovative product design.
- Interface with clinicians, marketing, and process development to understand customer preferences/requirements and establish design criteria for new products and product improvements.
- Interface with vendors to provide technical requirements, obtain quotations and monitor delivery of identified products or processes.
- Investigate or direct the investigation of product complaints to determine cause and implement corrective action as applicable.
- Represent Teleflex Medical R&D at hospitals, scientific sessions, and seminars to meet with medical personnel and discuss product line requirements and trends.
- Support regulatory submissions and clinical trials as required.
Education / Experience Requirements
- BS in Engineering, Computer Science, or Physics with advanced degree preferred.
Specialized Skills / Other Requirements
- Strong skills in software architecture design.
- Proficient in. NET environment and C# with 6+ years of experience.
- Ultrasonic, Doppler and ECG experience preferred. Experience with MATLAB and conversion of MATLAB to C environments preferred.
- Knowledgeable in theory and application of digital signal processing software.
- Knowledgeable in software configuration management and test methodologies
- Fundamental understanding of Quality Regulations and Design Control requirements.
- Experience with product development, product support, and product launches.
- Medical device development under design control
- Imaging, Vision/Sensor, Multi-threading, Data Handling, TCP/IP, Bluetooth
- Windows OS, Microsoft .NET Framework, Visual Studio, C#, C++,
- iOS and Android App development
- MATLAB, LabView
- Experience with cybersecurity for medical devices.