Staff Systems Engineer

ABOUT US 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 Staff Systems Engineer is responsible for helping shape future products as well as executing in the support of existing products.

They will perform analysis and modeling to support their concepts, and verify their designs will meet requirements.

The Staff Systems Engineer is a subject matter expert in medical device development requirements, 60601-1 documentation and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, IOVV.

SALARY AND PAY TRANSPARENCY 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.
• ESSENTIAL DUTIES & RESPONSIBILITIES 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 Create system level documentation to organize architectures, create strategies, and mitigate risk Direct supervisor 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 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 notified bodies Review system verification plan and system verification procedures Required Skills and Experience Expertise in medical imaging and scientific imaging technologies Expertise in medical device development Experience with optical concepts, optical design and camera technology Experience with measurement automation Experience shepherding product through 60601-1 / EMC testing Working knowledge of Scrum or other Agile development methodologies Broad knowledge of engineering concepts (EE, ME, SW, data analysis, modeling) Microsoft Word, Excel and Outlook or equivalent 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Education / Experience Typically requires a minimum of 8 years of related HW / SW / System / Optical experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent 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 public.
• Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

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

Benefits :

Plus, we work to maintain the best possible environment To Apply :