Sr. Systems Lead / Hardware Architect / Software Architect

Bambi Medical is looking for an enthusiastic, determined person willing to work in a dynamic start-up environment. 

Job Description

  •  Overall Technical leadership and responsibility of System or Sub-system definition to release and lifecycle management.
  •  System Integration & Technical Management liaison to the Program cross functional internal or external teams.
  •  As a key member of CTO Group responsible for technical roadmap inputs and advance research activities.

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.

Key skills

  • 8 to 10 years of experience in an engineering role in Class I/ II Medical devices 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.

 

If interested please send your CV and motivation letter to: Claudia@bambi-medical.com or Avi@bambi-medical.com

 

Systems Verification & Validation Engineer

Job Description

  • Overall responsible for System or Sub-system Verification & Validation for new release and lifecycle management.
  • Coordinates verification activities over internal & multiple external teams.
  • Leads 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.

Key skills

  •  5 to 8 years of experience in an engineering role in Class I/ II Medical Devices environment.
  •  Strong technical writing skills for generation of test specifications, build method, work instructions, technical protocols and reports
  •  Strong knowledge of testing methods at all levels (Unit, Integration, System V&V and Acceptance) applied within the development   lifecycle
  •  HANDS-ON knowledge of Verification & Validation planning, tools and processes related to 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.

If interested please send your CV and motivation letter to: Claudia@bambi-medical.com or Avi@bambi-medical.com

 

REGULATORY AFFAIRS & COMPLIANCE OFFICER

Bambi Medical is looking for an enthusiastic, determined person willing to work in a dynamic start-up environment. 

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.

 

If interested please send your CV and motivation letter to: Claudia@bambi-medical.com