Systems Engineer

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®,
True Digital Surgery 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

True Digital Surgery
, a

B. Braun company, is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.

The Staff Systems Engineer is responsible for helping shape future products as well as executing in the support of existing products. Ideally they have Systems Engineering experience with complex electro-mechanical systems and surgical navigation. Perform analysis and modeling to support their concepts, and to verify their designs will meet requirements. The Staff Systems Engineer is a subject matter expert in medical device development.

This includes requirements, 60601-1 documentation and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, trace matrices.

Salary range for this position is between $150,000 and $185,000. Base pay is dependent upon many factors, such as: training, transferable skills, work experience, education, business needs and market demands. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus and all applicable company benefits.

The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

• Lead the system architectural development of next generation highly technical medical products, including electrical, optical, mechanical, industrial design, and software development.
• Create system level documentation to organize architectures, create strategies, and mitigate risk.
• Direct support of the Verification and Validation team
• Owner of Verification and Validation activities per project schedules
• Develop system level requirements and verification/validation tests to cover all aspects of system performance.
• Work with project management to create schedule and cost estimates for project execution.
• Work jointly with regulatory affairs to prepare test results and submission to regulatory organization worldwide, including compliance with MDR and FDA.
• Maintain the traceability between system requirements and verification testing via Inputs Outputs Verification Validation (IOVV) matrix
• Own and maintain the system Risk Management File (RMF) via cross functional risk analysis, including essential performance
• Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
• Work closely with product management to understand/translate voice of customer. Participate in developing the voice of customer, including attending conferences, operating rooms and labs, and analysis of competitors product offerings and system configurations
• Coordinate technical design reviews with all levels of the organization.
• 60601-1 subject matter…