Biomedical 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 Biomedical Engineer II 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. Finally it involves creating and executing test protocols to verify and validate the next generation product designs, including support for all fillings 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Work on next generation 3D surgical digital robotic microscope hardware, and software solutions
- The BME II will work closely with cross-functional development teams to represent clinical value propositions for patients and providers throughout the design, development, and update of TDS products
- Ownership of product and component requirements documents. Write, execute, and document component and system verification protocols and test results.
- 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
- Responsible for completing documentation in accordance with IEC 62366 and IEC 60601-1-6.
- Perform system level and sub-system level risk analysis for usability and hazards per IEC 60601-1
- Provide support and/or ownership of validation protocols for pre-clinical or clinical testing. Work closely with partners and key opinion leaders to represent the voice of the customer in the design teams
- Represent the technical team in the defense of submissions to regulatory bodies, including the FDA and CE, for global clearance to sell product
- Contribute to research efforts to develop the next generation of TDS products
- 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.
Typically requires a fifth year college or university prrogram certificate, or two to four years related experience and/or training, or equivalent combination of education and 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.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
To perform this job successfully, an individual should have knowledge of 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.