Sr Systems Engineer

B. Braun; Goleta (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

B. Braun is seeking a Senior Systems Engineer in Goleta, California to lead the design and development of the next generation of robotic digital 3D surgical microscopes.

You will shape future products, support existing devices, and contribute to design verification and risk management efforts. Responsibilities include defining system requirements, performing concept studies, and coordinating with regulatory affairs to ensure MDR/FDA compliance across global markets.

Qualifications

• Typically requires a Bachelor's degree and 3-5 years of related experience.
• Advanced degree may substitute for experience.
• Equivalent work experience accepted.

Responsibilities

• Lead technical proof of concepts for next-gen medical devices.
• Coordinate regulatory and MDR/FDA documentation activities.
• Create system-level requirements and risk analyses.
• Collaborate with product management and labs.
• Own RMF and IOVV traceability.

Skills

Systems architecture

Technical analysis

Documentation

Team collaboration

Education

Bachelor's degree in Engineering

Tools

MS Word

Excel

Regulatory testing tools

Job description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Company: Digital Surgery Systems Inc.

Job Posting Location: Goleta, California, United States

Functional Area: Information Technology

Working Model: Onsite

Days of Work: Monday, Wednesday, Tuesday, Friday, Thursday

Shift: 5X8

Relocation Available: Yes

Requisition ID: 14082

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

SUMMARY

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
• Understand clinical and technical needs to support platform approaches to align technologies like navigation, robotics and visualization across active medical devices.
• Align Data-, Software- and Hardware products and ensure the reusability within different product portfolios.
• Strong software focus with embedded and cloud software, knowledge in data interfaces and data architectures.
• 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

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

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Typically requires a Bachelor's degree and a minimum of 3-5 years of related experience; or an advanced degree without experience; or equivalent work experience.

Language

Ability to read, analyze, and interpret professional journals, technical procedures, or 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

• Expertise in medical imaging and/or scientific imaging technologies
• Expertise in medical device development
• Experience with optical concepts, optical design and camera technology
• Experience with measurement automation
• Experience shepharding product through regulatory and/or EMC testing
• Broad knowledge of engineering concepts (EE, ME, SW, data analysis, modeling)
• Microsoft Word, Excel and Outlook or equivalent

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.

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 .