Validation & Verification Test Engineer

Contribute to advancing robotic-assisted surgery while working for a company that respects, values, and appreciates all team members!

Why you will love working at Virtual Incision:

• Strong mission to expand access to robotic-assisted surgery, one of the most exciting fields in healthcare today.
• Company-wide dedication to clinical excellence, innovation, and teamwork
• Friendly, open, and fun culture where people genuinely like each other
• Opportunity to take ownership on exciting projects from day one.
• Career development through fast pace and an all-hands-on-deck culture
• Mentorship from some of the top industry experts
• Flexible working hours, including paid vacation and holidays.
• Healthcare programs including medical, dental, vision, disability, and life insurance.
• 401(k) retirement plan

Job Summary:

As a validation and verification test engineer at Virtual Incision, you will be part of a team that is designing, prototyping, testing, and producing cutting-edge miniature surgical robots that advance the field of surgery.  You will contribute to all aspects of system-level and component level verification and validation testing.  Both hardware and software testing will be performed.  You will work on projects from conception to manufacture, collaborating with electrical engineers, software engineers, scientists, surgeons, vendors, and other subject-matter experts to ensure our work continues to enhance patient outcomes while providing excellent value for our customers.

Responsibilities:

• Provide technical direction and oversight of V&V test method development activities. 
• Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification. 
• Participate in the planning and execution of technical project work regarding product testing. 
• Collaborate with Systems and Engineering teams to understand and derive specifications for a broad portfolio of VIC products.
• Create and document test methodologies and provide feedback and recommendations for product/design changes.
• Support project plan development and contribute to the development of the Design Verification and Validation strategy.
• Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation. 
• Ensure compliance with company quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and company safety regulations, policies, and procedures.
• Support early testing and assist product teams in determining key findings and collaborate to enhance the overall systems’ design and performance.
• Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements.
• Ability to use critical thinking to scale up/down priorities and level of depth of verification activities, based on impact on product quality/patient safety and client expectations.
• Develop system, integration, and regression level test scenarios for new product development.
• Author and update test protocols as need for new product development.
• Execute verification and validation tasks according to development lifecycle timelines.
• Write reports and log issues for executed verification tests. 
• Lead technical reviews and participate in system design reviews.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in mechanical engineering, biomedical engineering, or related technical field.
• 1-3 years of experience of multi-cycle V&V experience preferably in a medical device or a highly regulated industry
• MUST have experience with writing test automation scripts or a background in development.
• Good mechanical aptitude and ability to design complete test fixtures. 
• Demonstrated working knowledge of test engineering principles and scientific methods.
• Effective verbal and written communication skills. 
• Working knowledge of Statistics and statistical methods of inference and sampling methodologies.
• Ability to mentor, guide, and train other engineers in the complexities and nuances associated with V&V on complex systems. 
• Experience using the following software packages: Minitab, Jira. 
• Experience developing Test Scripts using Matlab, or other scripting tools.
• Problem-solving and design experience required.
• Experience in robotics engineering preferred.
• Knowledge of FDA Quality System and Design processes preferred.
• Previous medical device or other regulated industry preferred.

Salary:  DOE

Status:  Exempt