Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
Review system/product requirements and software architecture for medical device software and/or firmware. Design, develop, and debug new software and firmware products and/or enhancements for medical devices. Accurately document software/firmware design. Provide technical thought leadership in modern software engineering methodologies, techniques and tools. Support the adoption of new software engineering methodologies and tools (e.g. Agile techniques, Continuous Integration, Regression Test Automation, et cetera). Work with systems employing micro-controllers, micro-processors and DSPs; this may include project and product definition, design specification, project scheduling planning and documentation, coding and testing. Team player that is willing / able to enthusiastically take on almost any assignment to make the team successful and achieve business objectives. Able to effectively communicate with engineers, management, QA and Regulatory Affairs. Helps ensure all programs are completed in compliance with company design control policies and procedures.
In this job, you will:
- Develop software solutions of high complexity for medical device applications and perform unit testing of medical device software; by designing, developing, and performing coding related to bug fixes, enhancements for existing products and new features for new product releases, and analyzing system specifications, translating system requirements, and assigning task specifications to less experienced engineers.
- Confirm compliance by staying up-to-date and following all quality system procedures related to this job, which can affect the quality of products or services provided to our customers; and writing system documentation, including specifications, high-level documentation and project development information to conform to all applicable procedures and FDA design control requirements.
- Write system documentation, including specifications, high-level documentation and project development information to conform to applicable procedures and FDA Design Control requirements.
- Develop needed changes to assure production of a quality product by developing new complex programs and proofing programs ensuring logic and syntax are correct and program results are accurate, supporting other engineers with programming assignments.as well as responding to bug reports; reviewing and repairing legacy code; and maintaining client databases. Perform original software designs for medical device applications, which may include real-time data acquisition, communications, complex calculations and computer graphics.
- Analyze and understand existing products and their implementation, to determine optimal design and method to use for adding and/or changing features and functionality.
- Meet all project scheduledeadlines by planning individual workload and participating in periodic specification and/or technical design reviews with other technical personnel and product management, to verify progress and provide a formal communication path for questions, concerns and general information.
- Define verification and validation requirements for medical product designs. Perform test reports.
- Conduct and/or participate in specification and/or design reviews with other technical personnel and product management.
- Provide feedback to analysis/training staff about performance considerations/usability issues concerning software specifications and implementation by communicating with engineers and manufacturer's technical support staff regarding programming needs and performance. Provide training and technical assistance to other project and support personnel as required.
- Support other functions like marketing, customer service, hardware development and verification and validation by providing answers to product questions and advising implementation decisions and providing assistance to testers and support personnel as needed to determine system problems as well as reviewing changes in code and the environment that will affect system performance.
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Other duties may be assigned. Minimal travel is required (up to 10%).
- Bachelor's degree (B.S.) or equivalent in Computer Science, System Engineering, Electrical Engineering or other engineering discipline; or four to ten years related experience and/or training; or equivalent combination of education and experience.
- Advanced software architecture / engineering skills in the following: C, C++, C#, Visual Basic, .NET, DSP assembly language.
- Practical experience with Requirements Management tools, Oracle Agile PLM and LabVIEW .
- Able to work with Networking environments and interfaces, components including a variety of servers.
- Experience working with audio/visual computer components and accessories.
- Prior experience architecting/engineering complex systems and highly technical software.
- Read, analyze, interpret and write real time C/C++ for embedded systems.
- Embedded Firmware development, including coding for DSP, micro controllers, RISC and CISC micro processors. Experience in Atmel processors.
- Operating Systems, including device drivers, kernel development, debugging
- Hardware/software troubleshooting, including experience with oscilloscopes, logic analyzers, emulators, and other electronic instrumentation.
- Communication interfaces and protocols including USB, Ethernet, UARTs, and TCP/IP. Serial communication.
- Digital filtering
- Working knowledge of, and experience with CGMP, FDA QSR:21 CFR820 as applicable to Design Controls and Software Engineering in a manner that improves software/hardware development and product quality.
- Experience working with standards such as IEC 62304, ISO 13485 and ISO 14971.