V&V Manager Medical Robotics

The Galen Platform

Galen is developing a single-platform solution to aid surgeons across several disciplines with minimal disturbance to existing workflows. Our cooperative control paradigm aims to eliminate hand tremor and enable surgeons to realize precise minimally invasive interventions in otolaryngology, spine surgery, and tissue reconstruction that were previously considered beyond human capacity.

Our Story

Galen Robotics was founded in 2016 to commercialize the research done in the Laboratory of Computational Sensing and Robotics of Johns Hopkins University. Dr. Kevin Olds and Dr. Russell Taylor invented the Robotic ENT Microsurgical System (REMS) at JHU to prevent the complications caused by hand tremor in minimally invasive otolaryngological interventions.

Galen is expanding on this vision and technology.

The V&V Medical Robotics will be responsible for all aspects of the company’s V&V activities. This is a hands-on position where the V&V Medical Robotics will be responsible for leading the verification and validation efforts providing technical direction, strategy, and mentoring to V&V group.

Job Summary:  V&V Manager Medical Robotics

• Develop planning control of verification and validation activities.
• Hire and direct staff to meet scheduled commitments.
• Evaluating and understanding our current state of testing and driving change to increase test automation and improve our overall testing practices.
• Developing test strategies for test automation and manual verification and external validation.
• Develop the test development processes including: designs, reviews, implementations, and test execution.
• Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
• Work closely with other teams to build and maintain testing infrastructure and tooling.
• Work collaboratively with others to drive best practices and reduce cost of SW V&V effort.
• Assist engineering team in failure investigations/ root cause analysis for problems identified during lab testing and field issues.
• Periodically review how the test strategy aligns with the latest available technologies and industry trends
• Ensure that V&V testing is focused on meeting the customer requirements.
• Write test reports that summarize the compilation and analysis of basic reliability data from field studies.
• Need to clearly articulate design verification and stability process concepts to the business community through written and oral presentations.
• Ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the business.
• Understand and adhere to the company’s Code of Ethical Conduct and ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the business.
• Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.

Perform other duties as assigned.

Essential Functions:

• Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
• Support a work environment of continuous improvement that supports Galen’s Quality Policy, Quality System and the appropriate regulations for the area supported.
• Provide direction for improving the customer experience.

• Education Requirements: 

  Minimum BS in Engineering, Software preferred, 6 years of industry engineering experience

  Experience Requirements: 

  Minimum 5 plus years related experience in the medical device industry.

  Skills/Qualifications/Competencies:

• Demonstrated team building and leadership skills.
• Working knowledge of engineering design and test standards (e.g. IEC 60601, IEC 62304, etc.)
• Strong track record of independently analyzing test data and assessing compliance with performance requirements.
• Effective troubleshooting skills to isolate test failures/anomalies and to develop recovery action plans.
• Computer skills sufficient to retrieve, manipulate, analyze, interpret, and present data.
• Knowledge of FDA design control requirements
• Demonstrate ability to condense complex requirements into specific and measurable test objectives.
• Professional and positive approach, self-motivated, team player, creative with the ability to work on own initiative.
• Demonstrated strong oral and written communication skills.
• Proven leadership capabilities including strategy development, effective decision making, and the ability to drive results.
• Self-motivated, self-directed, and able to thrive in a fast-paced environment.
• Ability to work cross-functionally with a distributed team across Engineering, Design, Customer Success, Marketing and Business Development.

All your information will be kept confidential according to EEO guidelines.