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 www.bbraunusa.com
 
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. 

SUMMARY

The Senior Systems Integration & Test Engineer is responsible for helping shape future products as well as executing in the support of existing products. Ideally, they have experience integrating complex electro-mechanical systems, specifically involving active robotics, high-speed digital imaging, and precision optics. This role owns the formal verification process & strategy, leads iterative integration testing as the “tip of the spear” for sub-system integration, and ensures the system performs reliably in a clinical environment. The Senior Systems Integration and Test Engineer contributes to general systems engineering tasks, including requirements development, risk management (ISO 14971), and maintaining traceability throughout the design lifecycle.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: (Other duties may be assigned.)

• Lead the functional integration of hardware, software, firmware, and optical subsystems into a cohesive robotic microscope platform.
• Develop and execute iterative testing and characterization experiments during early prototyping through system hardening to assess system performance and stability.
• Characterize system performance with a focus on the intersection of features – such as opctical quality, robotic movement and computer vision.
• Owner of Formal System Verification activities, including authoring protocols, executing formal runs, and generating reports. Coordinates other teams and resources assisting in Formal System Verification.
• Review and collorabate to develop system-level requirements, ensuring they are unambiguous, testable, and traceable.
• Perform root cause analysis on complex system failures (hardware/software interactions) and drive defects to resolution
• Design and build test fixtures, develop automated test scripts (Python, MATLAB, LABView),
• Collaborate with Validation Team to validate that system meets the user needs of a surgeon in a clinical environment
• Collarborate to ensure the traceability between system requirements and verification testing via Inputs Outputs Verification Validation (IOVV) matrix
• Contribute to the system Risk Management File (RMF) via cross-functional risk analysis, including DFMEA and UFMEA input
• Support the regulatory submission process by ensuring all V&V data meets the standards for FDA and MDR compliance.
• Participate in technical design reviews to provide "Design for Testability" feedback to the engineering team.
• Review verification plans and procedures generated by peers to ensure technical rigor, adherence to relavant standards and confirm they address requirements correctly

Education/Experience

Typically requires a minimum of 5 years of related HW/SW/System/Integration experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 2 years experience; or equivalent experience.

Language

Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

Additional Skills

• Experience in medical imaging and scientific imaging technologies
• Experience in medical device development
• Experience with optical concepts, optical design and camera technology
• Expertise in writing and executing formal System Verification protocols for medical devices
• Expertise with scripting languages for test automation and data analysis (Python, MATLAB, LABView)
• Experience with robotics, motion control, and optical systems
• Experience in Requirements review for testability
• Experience troubleshooting complex electro-mechanical assemblies in-person and using debug logs
• Knowledge of testing for IEC 60601-1 and EMC compliance
• Working knowledge of Quality Management Systems
• Workling knowledge of Risk Management
• Broad knowledge of engineering concepts (EE, ME, SW) and how they interact in a system

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.   Specific vision abilities required by this job include color, stereoscopic and close vision. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to computer systems and electrical devices. The noise level in the work environment is usually low to moderate.

    
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.</p> <p>B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at <a href="http://www.bbraunusa.com">www.bbraunusa.com</a>.</p> <p>Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</p> <p><em>We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, <a href="https://www.eeoc.gov/poster">click here</a>.</em></p>
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.