Sr Design Assurance Engineer (Software Medical Devices) - 13757

B. Braun Medical, Inc. Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Bethlehem, Pennsylvania, United States Functional Area: Quality Working Model: Hybrid Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 13757 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com Position Summary Lead quality and compliance activities for the development of innovative medical devices with embedded and standalone software. Serve as a subject matter expert in Design Controls, Risk Management, Human Factors, Software Lifecycle Processes, and Cybersecurity , ensuring products meet regulatory, quality, and customer requirements from concept through commercialization. Key Responsibilities Provide Quality Engineering support for new product development, design changes, and OEM projects. Lead Design Control, Verification & Validation, and Risk Management activities. Develop and review quality plans, validation plans, design documentation, traceability matrices, and risk assessments. Ensure compliance with IEC 62304, IEC 60601, IEC 62366, ISO 14971, FDA, and ISO 13485 requirements. Analyze quality metrics, identify trends, and drive continuous improvement initiatives. Lead root cause investigations, CAPA activities, and problem-solving efforts. Partner with R&D, Regulatory Affairs, Manufacturing, and external stakeholders to achieve project and quality objectives. Present quality and compliance updates to leadership and project teams. Required Qualifications Bachelor's degree in Engineering or related View the full job description on the employer's website. Equal employment opportunity, including veterans and individuals with disabilities. PI287044545 / 13-1082.00 Project Management Specialists