Staff Biomedical Engineer
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 Staff Biomedical Engineer will be responsible for contributing to the design and development of the next generation of 3D digital surgical microscopes. This role involves becoming a subject matter expert in clinical procedures in the fields of neurosurgery, reconstructive surgery, and others as required. The role will build deep expertise in anatomy, surgical workflows and undertanding / interpreting the voice of the customer. In addition, this position will conduct research on next generation clinical solutions, and communicate with engineering teams to provide requirements. The Staff Biomedical Engineer will lead a team to organize and track verification and validation efforts, as well as creating and executing test protocols for the next generation product designs. Finally, this role will contribute to all filings with the FDA, and other regulatory organizations globally. This role involves working closely with internal and external cross-functional team members. It requires strong written and verbal communication and influencing skills, and the ability to work independently.
SALARY AND PAY TRANSPARENCY
Salary range for this position is between $80,000 and $120,000. 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, equity, 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 AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Contribute to the design and development of hardware, and software for implementation in medical, scientific, manufacturing, or R&D applications, following the Design Control procedures of the company
- Become a clinical subject matter expert, involving the study of literature, database analysis, animal labs and visits to operating rooms to build knowledge about relevant anatomy, clinical terminology, surgical techniques, procedure workflow and user interfaces
- Create and manage user needs and validation activities during product life-cycle development processes
- Engineering lead for the development and execution of verification and validation test plans
- Engineering input to technical and system requirements, capacity, and cost to develop a system
- Represent the technical team in the defense of submissions to regulatory bodies, including the FDA and CE, for global clearance to sell product
- Responsible for completing documentation in accordance with IEC 62366 and IEC 60601-1-6, usability engineering
- Create and maintain design documentation, such as descriptions, flowcharts, diagrams, and release notes
- Work with project managers to ensure that projects are completed on time, and within budget
- Ability to travel domestically 10% of the time
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.
- Bachelor's degree or higher in Biomedical Engineering or other equivalent science/engineering degree from an accredited university, plus 5-10 years related work experience.
- Knowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, X-rays, CT scans, MRI, OCT, etc.
- Experience being in the operating room (OR) supporting live surgeries as a design engineer, tech. support, service engineer, or sales representative. Knowing OR sterility protocols, medical equipment
- Understanding basic image processing concepts and techniques
- Skills for mathematically modelling and characterizing systems
- Basic knowledge of the anatomy and physiology
- A working knowledge of engineering design tools (i.e. schematic layout, PCB design, or CAD/CAM software). Hands-on background in operation and use of standard test equipment; oscilloscopes, digital multimeters, frequency generators, calipers etc. Ability to troubleshoot and analyze electronics.
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.