Sr Principal Engineer R&D

Displays and excels in standard engineering principles to develop creative solutions to challenging issues associated with the design, development, and sustaining engineering for Baxter’s Advanced Surgery business. Achieve desired technical outcomes through the direct completion of Design Control, CAPA, CC project deliverables or programs within the boundaries of timing and budget. Responsible for technical oversight of a constantly changing portfolio that impact R&D, Operations, Quality Systems (QS), Process, Customer or Supply Chain. Lead and collaborate with cross-functional teams to meet schedule & project demands. Based on technical expertise, review and approve design changes and provide technical product direction for the project team. Foster an environment of rigor, completeness and compliance when participating on CAPA, CC or FCA investigations/assessments. Handle project escalations and responsible for triage escalation to organization leadership. Embrace accountability for critical decisions as a technical subject matter expert within a cross-functional team to drive product development deliverables, such as formulation development, process development, or tech transfers. Demonstrate understanding of and adherence to FDA, ISO, and IEC design control procedures and standards. Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area. Provides technical leadership to project teams working closely with the Project Manager, Quality, Manufacturing Engineering, and key technical core team members, guiding them in terms of problem resolution, process clarification, referrals to appropriate experts, etc.