Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS), looking for an awesome V&V manager join our R&D department that is reshaping MIS.
The V&V manager is responsible to manage and shape the Verification & Validation team. The team collaborates closely with all R&D Engineers, Architects, product and operations to develop and commercialize the company’s family of products.
The V&V engineers are an integral part of all product research, development, integration and testing. The team manager’s position requires strategic and tactical thinking, agility, attention to details, and a diversified skillset to head many different tasks and operations. If you are up for the challenge, don’t miss this opportunity, we’d love to have you on our team.
- Manages and shapes the V&V team to accommodate all testing needs (research, feasibility, system) in Human Xtensions.
- Works closely with team members and take ownership – mentoring junior engineers
- Leads development, implementation, and maintenance of Design Verification & Validation (V&V) methodologies and best practices to influence product launch timelines, improve implementation of design enhancements and reduce the number of design iterations.
- Leads product verification and validation planning, resolution of technical integration issues, system testing, documentation and coordination and interfaces all related departments in the company.
- Represent the voice of Verification and Validation on the project team.
- Provides engineering expertise in system verification and establishes system V&V plans, assists in developments and of protocols and reports, as well as reviews.
- Implements design for testability by collaborating with R&D teams to evaluate requirements for test-ability. Collaborates with external agencies for compliance and safety certification.
- Bring up of testing automation methodologies and equipment
- Manages Human Xtenstions testing labs and equipment – Enforces safe laboratory regulations and practices including managing the test and measurement device calibration.
- Conducts design reviews from a V&V perspective as part of the product development process to ensure requirements are met and the designs resolve all feasibility verifications and future Design Verifications.
- Minimum of a BS in-Computer Science/Engineering, Electrical, Mechanical, Biomedical Engineering, or other related discipline. (MS, Ph.D preferred)
- Minimum 5+ years of experience successfully developing complex medical device (hardware, software, consumables) products for acute care/hospital markets
- Minimum of 3+ years of functional management experience
- Knowledge of Statistical Data Analysis – Including the ability to evaluate proposed study designs, the calculation of sample sizes and/or estimation of statistical power.
- Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating and analyzing test reports
- Understanding of global medical device regulatory environments and clearance processes (such as ISO 13485 and IEC60601).
- Good communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.
- Test Automation Experience with emphasis on automation equipment bring up and validation
- Data-driven approach – always looks for the essence of design and process moves teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
- Relentless focus on Quality and Transparency as an organizational value.
- Makes things happen by encouraging and channeling the contributions of others; recognizing and addressing important issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.