Are you passionate about developing state-of-the art technologies? Are you looking for an ambitious new project to test and grow your skills?
Come join our well-funded med-tech start-up company Bambi Medical located in the Dutch Silicon Valley, High Tech Campus, Eindhoven and help make babies lives happier from day one.
Founded in 2016 Bambi Medical develops its first product a wireless neonatal vital sign monitoring system - the Bambi Belt Solution. The original concept for the system was created by neonatologist and founder of the company, Sidarto Bambang Oetomo at the department of Industrial Design at TU/e. The Bambi Belt Solution effectively measures vital signs (ECG, temperature, respiration) of premature babies in a skin friendly and wireless way.
The Bambi Belt Solution aims to replace the current global standard of adhesive electrodes. It will help reduce the pain and stress attributed to the use of adhesive electrodes. The Bambi Belt Solution will also facilitate easier handling by nurses and parents for optimized Kangaroo Mother Care, the skin-to-skin contact between parents and baby, which according to the World Health Organization has proven be essential for parent-child bonding while Improving long-term clinical outcomes.
We are looking for an experienced System or Sub-system Verification & Validation engineer who will be responsible for the product release and lifecycle management. As a V&V Engineer you will coordinate verification activities with our internal team and our partner companies such as Holst Centre, ItoM Medical and more. You will also lead the development of Verification & Validation test strategies.
- System or Sub-system requirement review to ensure that requirements are actionable, measurable and testable.
- Create test plans, test cases and test reports independently with very little supervision. Create, review and optimize test design, reusable test cases and test procedures to ensure complete functional and non-functional test coverage.
- Maintain production-like test environment for formal verification and subject to strict change control.
- Create clinical relevant end to end user scenarios, provide needed training to users.
- Evaluate new product/process technology (internal or external), fixture design, tooling, equipment features/changes, and test methods.
- Define and measure key progress indicators on requirement coverage, test case effectiveness, Test execution and defect identification and closure.
- Develops statistical analysis and problem solving. Development of statistical rationale plans for development studies techniques.
- Review and approve executed test results to confirm test results provide proper objective evidence requirements are met and are compliant to the verification & validation process.
Desired skills and experience
- At least 5 years of experience in an engineering role in class I/II medical device environment.
- Strong knowledge and experience with Medical Regulatory Requirements associated with design controls - MDD, ISO 13485 and ISO 14971.
- Hands on experience on FMEA, Fault Tree analysis, Reliability block diagrams preparation and RCA techniques.
- Demonstrated capability to conduct and lead technical reviews of product design elements.
- HANDS-ON knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking and field feedback.
- Ability to work independently or as part of a group, with excellent written and oral communication skills.
Flexible and fun working environment.
Excellent growth and advancement opportunities.
An opportunity to work independently in an international and dynamic start-up environment.
Great location and inspiring environment of High Tech Campus, where more than 200 companies develop state of the art technologies.
Send your CV and motivation letter firstname.lastname@example.org.