Principal Engineer R&D

Display and excel 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. Participate with cross-functional teams to meet schedule & project demands for product sustenance. Based on technical expertise and direction of product owner, review and access design changes and provides technical product direction for implementation. Develop and maintaining technical documentation, including technical specifications, design documents, and labeling. Fosters an environment of rigor, completeness and compliance when participating on CAPA, CC or FCA investigations/assessments. Collaborate with regulatory agencies and quality teams to ensure compliance with relevant regulations. Conduct root cause analysis and problem-solving for complex technical issues. Demonstrate understanding of and adherence to FDA and ISO design control procedures and standards. Use critical thinking and teamwork to contribute to the resolution of competing constraints. Create and maintain technical documents found in a DHF, such as verification/validation reports, technical drawings, and specifications.