As the V&V Lead, you will be responsible for leading the verification and validation activities for the Bambi Belt Solution. You will oversee the planning, execution, and documentation of V&V processes, ensuring compliance with industry standards (such as MDR, ISO 13485, IEC 60601, and IEC 62304), and that our products meet the highest safety and performance standards. Your leadership will be crucial in maintaining a rigorous and systematic approach to the testing and validation of our devices, ultimately ensuring that they are safe, effective, and ready for market.

• Lead the development and execution of V&V plans for the Bambi Belt Solution.
• Collaborate within a cross-functional team, to ensure proper integration of V&V activities.
• Oversee the creation and review of V&V test protocols, including test cases and acceptance criteria.
• Manage the execution of verification and validation testing, ensuring all testing is conducted per the defined plan and in compliance with regulatory requirements.
• Ensure that all V&V activities are documented thoroughly and that results are analyzed and reported accurately.
• Review and approve test reports, ensuring completeness and compliance with quality standards.
• Coordinate and facilitate risk-based V&V activities, including risk assessments and failure mode analysis (FMEA).
• Lead root cause analysis and corrective/preventive actions in response to product issues identified during V&V testing.
• Maintain up-to-date knowledge of regulatory requirements (MDR, ISO 13485, IEC 62304,...) and industry best practices, ensuring all V&V activities align with these standards.
• Foster continuous improvement within the V&V process.
• Support regulatory submissions, audits, and inspections related to V&V activities.

• Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, or a related field.
• Proven experience in Verification and Validation (V&V) activities for medical devices, with a strong understanding of V&V processes and methodologies.
• Deep knowledge of relevant medical device regulations (MDR, ISO 13485, IEC 60601, IEC 62304) and industry standards.
• Experience with V&V documentation practices, including risk management and design control.
• Strong analytical skills and the ability to interpret complex technical data.
• Excellent project management skills, including the ability to manage multiple priorities.
• Proven ability to work collaboratively in a multidisciplinary team environment.
• Strong communication skills, both written and verbal, with the ability to present complex information to stakeholders.
• Detail-oriented with a focus on quality and compliance.

• Experience with Agile or other product development methodologies.
• Certification in V&V (e.g., Certified Quality Engineer, Certified V&V Specialist).
• Experience in leading V&V activities for Class II medical devices.
• Familiarity with test management tools and software.

• Competitive salary and benefits package.
• Opportunity to contribute to innovative and life-changing medical technologies.
• A dynamic, collaborative work environment.
• The chance to be part of a team that is shaping the future of healthcare.

Interested candidates should submit their resume and cover letter to info@bambi-medical.com.