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.
You will work together with the CTO group and will be responsible for the product’s technical roadmap inputs and advanced research activities. The ideal candidate for this position will have seasoned, hands-on experience providing technical management and system integration. As senior lead system engineer you will manage multiple sub systems with both our internal team and our development partners such as Holst Centre, ItoM Medical and more.
- Owner of System & Sub Systems Specifications – Overall translation of User, Regulatory, Manufacturing & Service requirements
- Design Requirements Management, Decomposition of derived requirements and traceability.
- Design feasibility of potential solutions, design options and decision.
- Design Risk Management - Risk Evaluation and Assessment.
- Defect Management/Root cause analysis, debugging and problem solving.
- Design process compliance assurance, design quality assurance and design reviews.
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 to firstname.lastname@example.org