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**V&V Manager Medical Robotics

2 months ago

Baltimore, Maryland, United States Galen Robotics Full time
Job Summary:

The V&V Manager Medical Robotics will be responsible for leading the verification and validation efforts at Galen Robotics. This is a hands-on position where the V&V Manager Medical Robotics will provide technical direction, strategy, and mentoring to the V&V team.

Key Responsibilities:
  • Develop Planning and Control of Verification and Validation Activities: Create and implement plans for verification and validation activities to ensure compliance with regulatory requirements.
  • Hire and Direct Staff: Recruit, train, and manage a team of V&V professionals to meet scheduled commitments.
  • Evaluate and Improve Testing Practices: Assess the current state of testing and drive change to increase test automation and improve overall testing practices.
  • Develop Test Strategies: Create test strategies for test automation and manual verification and external validation.
  • Develop Test Development Processes: Establish processes for test design, review, implementation, and execution.
  • Improve Testing Methodology: Continuously improve testing methodology, best practices, and standards to provide consistent testing across products.
  • Collaborate with Other Teams: Work closely with other teams to build and maintain testing infrastructure and tooling.
  • Drive Best Practices: Collaborate with others to drive best practices and reduce the cost of SW V&V effort.
  • Assist Engineering Team: Assist the engineering team in failure investigations and root cause analysis for problems identified during lab testing and field issues.
  • Review Test Strategy: Periodically review how the test strategy aligns with the latest available technologies and industry trends.
  • Focus on Customer Requirements: Ensure that V&V testing is focused on meeting customer requirements.
  • Write Test Reports: Write test reports that summarize the compilation and analysis of basic reliability data from field studies.
  • Communicate with the Business Community: Clearly articulate design verification and stability process concepts to the business community through written and oral presentations.
  • Ensure Compliance: Ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations, and laws applicable to the business.
  • Maintain a Professional Image: Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
Qualifications:
  • Ensure Compliance with Regulatory Requirements: Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
  • Support a Culture of Continuous Improvement: Support a work environment of continuous improvement that supports Galen Robotics' Quality Policy, Quality System, and the appropriate regulations for the area supported.
  • Provide Direction for Improving the Customer Experience: 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, strong track record of independently analyzing test data, effective troubleshooting skills, computer skills sufficient to retrieve, manipulate, analyze, interpret, and present data, knowledge of FDA design control requirements, 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, 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.