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Design Control Specialist (Maternity Cover) in MedTech Start-up

We are looking for an ambitious and skilled design control specialist with deep knowledge of ISO 13485.

About us

BluSense Diagnostics is an innovative start up in the MedTech business, working hard to become global leader within the infectious point-of-care diagnostics! We combine complex scientific areas such as nanotechnology, molecular biology, biochemistry, optics, and hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases.

The job

We are looking for a Design Control Specialist in the Product Development Team that plays numerous key roles in developing technical solutions, delivering design control documentation, and performing usability activities during the course of IVD product development.

As a Design Control Specialist you will be responsible for generating and supporting design control deliverables and activities related to IVD product development projects. The position requires knowledge of working in a regulated environment.

The position is a maternity cover.

Your responsibilities

  • Author and review design control documentation to support regulatory filings
  • Coordinate risk management activities
  • Plan design verification and validation activities for a novel IVD test
  • Collaborate with R&D, QA, RA, Marketing, Usability, and Manufacturing team members
  • Continuous improvement and optimization of BluSense’s design control processes and templates in collaboration with RA/QA
  • Ensure that project deliverables are in compliance with BluSense Diagnostics QMS.

Your qualifications

We are looking for a M.Sc. in a relevant scientific field, e.g. molecular biology, chemistry, pharmacy, nanotechnology or equivalent and we require that you have a minimum of 2 years of experience with design control activities for IVDs or medical devices. It is key to us that you have knowledge of the standard ISO:13485 and if possible, experience in working with microfluidics/point-of-care devices.

Your personal skills

  • Fluency in English, both verbally and in writing
  • Ability to work in an international, fast-paced environment with cross-functional teams
  • Strong team spirit and enthusiasm
  • Structured and ability to keep a clear overview
  • Detail-oriented
  • Strong writing skills.

We offer

  • Work in a young, international and highly motivated team
  • Have a leading role in bringing to market a novel point-of-care device
  • Competitive salary.

How to apply

Therefore, please submit your application and CV in one pdf file via "Apply online" as soon as possible and no later than June 18th, 2019. Qualified applicants can expect to be called for an interview ahead of the deadline.

We plan to hire for a job start in July/August 2019.

Please reach out to David Hersi Smith, Product Development Manager (david.smith@blusense-diagnostics.com) if you have any questions about the position or about BluSense Diagnostics.

Apply online Gem job

Arbejdssted

Copenhagen

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