This position is responsible for leading software and systems design, implementation and tests for new electromechanical devices, and for enhancements and support of existing safety-critical electromechanical devices. Execute according to software standards for life cycle, documentation, development methods, testing, and maintenance. This position requires a cross-functional communication and the ability to lead specific projects or technical initiatives.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Follow procedures for proper development and control of design plans, design inputs/design outputs, and the approval of the affected documents in all phases of the development lifecycle.
3. Provide technical assistance and leadership required to plan and implement software projects, including organizing and leading members of various departments, planning and scheduling, coordinating resources, preparing proper documentation, etc. in a manner consistent with company objectives.
4. Lead and manage all aspects of software development including requirements definition, design documentation, design and development reviews, traceability, testing, issue tracking, configuration management, verification and validation, and adherence to software related standards as mandated by the organization’s quality system.
5. Represent the software organization in a cross-functional manner by providing engineering knowledge to develop new products or improve existing products/processes and implement software solutions for engineering problems.
6. Apply broad engineering knowledge to setup software development environments, select real-time operating systems, specify development tools, and create proper level of design documents as required by the applicable regulatory standards for existing and new products.
7. Assign work to temporary workers as needed. Oversee outside suppliers and consultants as required.
8. Support audit activities, investigate customer complaints and recall issues of product software, and provide root cause analysis and propose solutions.
9. Implement comprehensive educational plan to develop, maintain, and expand state-of-the-art knowledge in areas of specialization. Maintain knowledge of current competitive technologies in medical, biomedical, and other technical developments related to company products, though actions such as professional memberships, attendance at conferences and/or seminars, subscription to trade magazines, etc.
10. Contribute to the intellectual property position of the company via invention and patent applications.
11. Maintain awareness of current patent and journal literature in areas of responsibility. Develop a knowledge and understanding of Terumo’s products, customers, and customer needs.
12. May utilize the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
13. Perform other duties as assigned. |
