Sr 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® 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

The Senior Systems Engineer leads a technical program to analyze, design, and develop the next generation of robotic digital 3D surical microscopes. The Senior Systems Engineer will be responsible for helping shape future products as well as supporting existing products. They will perform analysis and modeling to support their concepts, and to verify their designs will meet requirements. The Senior Systems Engineer should be comfortable with requirements, documentation, and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, and architecture.

• Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
• Lead the system architectural development of next generation highly technical medical products, including electrical, optical, mechanical, industrial design, and software development and integration.
• Create system level documentation to organize architectures, create strategies, and mitigate risk.
• Develop system level requirements to cover all aspects of system performance.
• Work jointly with regulatory affairs to prepare test results and submission to regulatory organization worldwide, including compliance with MDR and FDA.
• Own and 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
• 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 expert for technical peer reviews
• Coordinate external testing with certified labs
• Review system verification plan and system verification procedures

To perform the job successfully, an individual should demonstrate the following competencies:

Complexity – Works on problems of basic scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within very defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Knowledge – Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Teamwork
- Balances team and individual responsibilities;
Exhibits objectivity and openness to others’ views;
Gives and welcomes feedback;
Contributes to building a positive team spirit;
Able to build morale and group commitments to goal and objectives;
Supports everyone’s efforts to succeed;
Recognizes accomplishments to other team members

Supervision
- Normally receives instruction on day-to-day work, general instructions on new assignments.

Leadership
- Given an introduction to the context in which a task fits, can design and complete a small to medium sized task independently

To perform this job successfully, an individual must be…