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Verification & Validation Manager

About us

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.

Responsibilities

  • 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.

Requirements

Basic Qualifications

  • 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.
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