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40 uur - Bambi Medical

Systems Manager

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Full-time

Bambi Medical is a startup that operates in the NICU space, with the vision to reduce pain and stress in babies and improve the parent-child bonding. The first product that we are launching is Bambi Belt. It acquires ECG and Respiration from premature babies in a less stressful way. We are currently finalizing the development of our first generation product! Have you always wanted to work on new technology and innovation that helps the society? Join us!


Job Description

In this role, you have an opportunity to:

Be part of a small team of experienced professionals working on all the product development aspects from drafting the requirements till performing validation and realizing the product. Alongside, interact with external development partners, manufacturing partners and the suppliers as part of product development. In this role you are the key person overseeing the entire product end-to-end from the belt up to and including the Bambi Monitor.

You are responsible for:

o   System & Sub Systems Specifications – Overall translation of User, Regulatory, Manufacturing & Service requirements, Lifecycle Management

o   Owner of System & Sub Systems Specifications – Overall translation of User, Regulatory, Manufacturing & Service requirements, Lifecycle Management

o    Design Requirements Management, Decomposition of derived requirements and traceability, guiding design and development during the engineering phase and system integration

o   Design feasibility of potential solutions, design options and decision

o   Design Risk Management – Owner of Risk Management File (Risk Evaluation and Assessment)

o   Defect Management/Root cause analysis, debugging and problem solving

o   Designing process compliance assurance, design quality assurance and design reviews

o   Ensuring compliance to all internal QSPs and industry regulations and contribute to the creation of the processes

o   Provide support for technical roadmap inputs and advance research activities.

To succeed in this role, you should have the following skills and experience:

o   Strong knowledge and experience with Medical Regulatory Requirements associated with design controls - MDD, ISO 13485 and ISO 14971 or willingness to acquire these competences by intensive training at the start of your assignment.

o   Hands on experience on FMEA, Fault Tree analysis, Reliability block diagrams preparation and RCA techniques

o   Demonstrated capability to conduct and lead technical reviews of product design elements

o   Knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking and field feedback

o   Ability to work independently or as part of a group, with excellent written and oral communication skills.

Qualifications Required for Position

Attitude:

o   A self driven individual with flexibility to adapt to situation and wear multiple hats on need basis.

o   In general, you are entrepreneurial and have proven problem-solving skills.

o   You like to play a pro-active part in the progression of yourself and the organization.

Technical:

o   Master’s degree (or same level with proven track record) in electrical engineering or electronics

o   Experience in a regulated field is preferred.

o   5+ years of professional experience required

 

If interested please send a short motivation letter together with your CV to: talent@bambi-medical.com

 

Vacature details



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