Careers
Do you want to design next-generation surgical robotic systems?
Virtuoso Surgical is a growing surgical robotic company based in Nashville, working towards commercialization of a new surgical robotic technology for endoscopic surgery. Product development at Virtuoso Surgical is fast-paced, hands-on, and surgeon-centered. Join the Virtuoso Surgical team and help shape the future of surgery.
We are currently hiring the following positions:
Senior Mechanical Engineer
- Lead mechanical design work for a novel surgical robotic system
- Help plan and execute development from prototype to FDA-approved product
- Design diverse components ,including electromechanical systems, structural assemblies, and cosmetic enclosures with concern for manufacturing and standards compliance
- Work on a dynamic team with diverse skill sets to create software-controlled mechatronic systems
- Work on multi-disciplinary team to develop system-level and subsystem product requirements
- Develop and implement verification testing plans for mechanical components and assemblies
- Coordinate with coworkers, vendors, and consultants to ensure completion of shared goals
- Interface with suppliers and manufacturers to determine best methods for production
- Develop risk mitigation plans and incorporate into the product design
- Provide support to regulatory and quality assurance teams
- Minimal travel required to attend trade shows and meet with suppliers/manufacturers; optional travel for professional development
Education/Experience Requirements
- 10+ years of experience in medical device product development
- Bachelor’s degree in Mechanical Engineering or related field
Skill/Knowledge Requirements
- Deep knowledge of the medical design development process (design controls) per FDA regulation and relevant international standards (e.g. ISO 13485)
- Excellent mechanical engineering fundamentals in the areas of machine design, materials, and design for manufacturing
- Experience designing mechanical assemblies and creating engineering drawings for manufacturing
- Strong hands-on engineering skills
- Experience leading teams and mentoring other engineers; project management/planning experience preferred
- Strong verbal and written communication skills
- Extensive experience with CAD software, SolidWorks preferred
- Experience with electromechanical systems and basic knowledge of electrical engineering principles, systems, and controls engineering
- Knowledge of medical device risk management process (ISO 14971)
- Knowledge of IEC 60601-1 preferred
- Experience designing disposable medical device components
- Experience designing for injection molding
- Experience with human factors engineering and human-centered design
Software Engineer
- Work on a multi-disciplinary team to develop, test, and document software for a Class II medical device
- Develop software in C++ and Java to control electromechanical systems
- Plan and supervise outsourced software development effort
- Ensure compliance with FDA regulations throughout the software development process
- Create and implement software and integration testing plans
- Design system architectures and create software specifications from product requirements
- Generate and review software planning documentation, SOPs, software verification plans, and test reports
- Participate in technical design discussions and design reviews to provide recommendations related to software
- Work on multi-disciplinary team to perform hazard analyses and FMEA; provide recommendations for risk mitigations
- Work closely with other engineering disciplines to design electromechanical systems and user interfaces
- Provide support to regulatory and quality teams as needed
Education/Experience Requirements
- 5+ years of experience writing software for medical devices
- Bachelor’s degree in Computer Science or a related field
Skill/Knowledge Requirements
- Deep understanding of development process for IEC 62304-compliant software
- Object oriented development experience, preferably C++
- GUI development experience, preferably with Qt
- Experience with software architecture design
- Embedded development experience
- Proficient in debugging using emulators and electronic test equipment
- Strong understanding of testing methodologies including automated unit testing and system integration testing
- Strong knowledge of medical software documentation
- Experience with hardware and electronics used in embedded systems
- Demonstrated ability to work collaboratively on cross-functional teams in a fast-moving environment
- Strong mathematical and analytical skills; working knowledge of robot kinematics preferred
- Experience with industrial controls/safety systems preferred
- Excellent written and verbal communication skills
Quality Systems Manager
- Facilitate all aspects of Virtuoso Surgical quality management, cultivating a quality-first and safety-first culture throughout the organization
- Create Standard Operating Procedures for design control and risk management and implement/coordinate with engineering team
- Work on a multi-disciplinary team to develop a complex medical device
- Ensure compliance with regulatory standards and industry best practices
- Identify training requirements and perform training
- Review design control documentation generated by the engineering team
- Perform residual risk assessments after testing
- Lead audit preparations for internal and regulatory audits
- Oversee Corrective/Preventative Action (CAPA) process
- Communicate with external suppliers and manufacturers to ensure compliance with our quality systems
Education/Experience Requirements
- 5+ years of experience in Medical Device Quality Systems
- Bachelor’s degree in a technical or science field preferred
Skill/Knowledge Requirements
- In-depth knowledge of FDA standards: 21 CFR-820, ISO 13485, and ISO 14971
- Experience working with product development/design control processes
- Experience with human factors testing and analysis, including experience with IEC 62366-compliant human-factors processes
- Experience with software quality, including knowledge of IEC 62304 and IEC 60601
- Experience with risk analysis processes
Engineering Technician
- Work on a multi-disciplinary team to develop a complex medical device
- Perform prototype assembly and hands-on fabrication
- Assemble, solder, and debug PCBs
- Test electronics with multimeters, oscilloscopes, etc.
- Operate and maintain fabrication equipment, including lathe, drill press, saws, and 3D printer
- Operate and maintain testing equipment
- Advise engineering team on useful design modifications/improvements
- Develop protocols for testing components and assemblies
- Perform verification tests, tabulate data, and create written and digital test reports
- Coordinate installation of new equipment; provide training to employees as necessary
- Maintain inventory of components and testing materials
Education/Experience Requirements
- 5+ years of experience in hands-on, technician role
- Associates Degree in technical field preferred but not required
Skill/Knowledge Requirements
- Excellent hands-on fabrication and assembly skills
- Strong mechanical design understanding and intuition
- Experience performing and documenting tests according to written procedures
- Experience assembling and debugging PCBs and electrical equipment preferred
- Ability to read mechanical drawings; drafting experience preferred
- Strong written and verbal communication skills
- Experience with Microsoft Word, PowerPoint, and Excel
- Must be self-motivated and able to work effectively without close supervision