SR. LEAD SYSTEM ENGINEER

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. 

About us

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.

The position

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. 

Key responsibilities

  •  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.

We offer

Competitive salary.

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.

Interested?

Send your CV and motivation letter to talent@bambi-medical.com

SYSTEMS VERIFICATION AND VALIDATION ENGINEER

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. 

About us

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.

The position

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.

Key Responsibilities

  • 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.

We offer

Competitive salary.

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.

Interested?

Send your CV and motivation letter talent@bambi-medical.com. 

COMPLIANCE OFFICER

Are you an experienced regulatory and compliance officer? 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 change start of the most vulnerable ones of our planet – premature babies.

Regulatory Affairs & Compliance Officer will work on:

  • Product compliance activities with the Medical Device Directive 93/42/EEC; Code of Federal Regulations 21 CFR Part 820 and BS EN ISO 13485:2012 / 2016.
  • Compliance and maintenance of technical files, design history files and regulatory submissions.
  • Supporting all compliance activities throughout the lifecycle of our products.

Key Responsibilities

  •  Technical File Generation.
  •  Risk Evaluation and Assessment.
  •  Support of Clinical evaluations and Post Market surveillance.
  •  Review technical standards and extract regulatory requirements for products. 
  •  Assist Change Management Process including proposing and implementing assigned changes.
  •  Complaints handling, monitoring and resolution. Support internal CAPA investigations.
  •  Support Internal & External Audit activities.

Key skills

  • Regulatory Affairs experience from a medical devices environment – At least 3 to 10 years experience in regulation of class I/ II medical devices.
  • Preferably good knowledge of one or more of the following

o   BS EN 62304 Medical device software - Software life-cycle processes

o   BS EN 60601 Medical electrical equipment - General requirements for basic safety and essential performance

o   BS EN 62366 - Application of usability engineering to medical devices

  •  Excellent knowledge of MDD, ISO 13485 and ISO 14971
  •  Ability to work independently or as part of a group.
  • Excellent written and oral communication skills of English are a must.

We offer

Competitive salary.

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.

Interested? 

Send your CV and motivation letter to talent@bambi-medical.com