Baxter is looking to advance the next generation of transformative healthcare innovations within its Healthcare Systems and Technologies segment, specifically focusing on the Patient Support Systems (PSS) portfolio. The goal is to accelerate patient recovery by providing clear visibility into patient status, enabling earlier issue identification, risk avoidance, and faster treatment. The Associate Director R&D will be instrumental in creating strategy and execution plans for PSS Systems and V&V engineering NPD, Sustaining, Connectivity, and Codes & Standards to achieve these objectives.
Requirements
- Systems engineering, V&V, etc
- Medical device/MedTech industry experience is required
- Strong knowledge of scientific/technical disciplines and solid knowledge of related disciplines such as Systems and V&V engineering, codes & standards, connectivity, regulatory, quality, and/or product development.
- Recognized internally and externally as expert in Systems and V&V Engineering and Connectivity
- Ability to design and implement projects/studies outside area of expertise
- Maintain current knowledge of relevant quality system regulations, FDA, EUMDR, and other global C&S/regulatory requirements related to research and development (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
- Effectively transfer technology from design development to implementation.
Responsibilities
- Oversee the development and/or sustaining of system architecture, requirements, risk management, connectivity, reliability, verification, validation, and C&S compliance.
- Provide technical leadership for teams to ensure the completion of complex projects and programs within boundaries of quality, time, and budget.
- Employ kaizen to create and implement best-practice methodologies and processes.
- Review and approve complex designs and provide direction to technical staff.
- Provide technical guidance for a large-scale program, or several small projects with complex features, in the areas of release of new products, product improvements, value improvements, changes in regulatory requirements, review supplier-initiated changes, and complaint investigations.
- Solve problems expeditiously through the use of multiple disciplines and technical principles.
- Create innovative products/processes/methods through novel combinations of expertise within the organization.
Other
- Create and communicate processes, standards or operational plans in support of the business vison and goals, ensuring industry leadership.
- Select, develop and retain teams that include technical contributors and managers/senior managers.
- Provide leadership to teams and team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
- Successfully coach, mentor and motivate others, and remove barriers to drive to exceptional performance.
- Provide leadership to cross-functional technical teams both internal and external to Baxter in accordance with best practices for innovation and new product development.
