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:

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

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

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

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

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