Systems Engineer II
True Digital Surgery 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 Systems Engineer leads a technical program to analyze, design, and develop the next generation of robotic digital 3D surical microscopes. The 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 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
include the following. Other duties may be assigned.
- 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 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.
Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
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.
- 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
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. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.
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 work near moving mechanical parts. The noise level in the work environment is usually moderate.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment
To respond to this opportunity, please apply through this ad.
For more information about us, please visit www.truedigitalsurgery.com
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.