Sunday, May 8, 2016

Senior Device Engineer - Kent - 45-55k




Senior Device Engineer – Kent – Circa 50k.


Fixed Term Contract – 18 months to Perm.


Location: South East, Kent.


Salary: Circa 50k.


The Role:


Project Management of internal and outsourced device development projects.


Key Responsibilities


  • Manage/ Progress device development.

  • Departmental activities – write, review and approve SOPs, Maintain development laboratory as per GLP (ensure equipment and instruments are maintained and calibrated).

  • Follow cGxP, ISO 13485, Regulatory Guidelines and H&S applicable to the job.

Knowledge:


  • A degree within an engineering or relevant scientific discipline

  • Masters in Scientific discipline (medical engineering preferably)

  • Preferably higher level qualification (PhD) (medical engineering related)

  • An excellent understanding of medical device development processes compliant with ISO 13485, QSR or experience of a similar quality system such as ISO 9001

  • Knowledge of device development within the medical device industry.

Experience:


  • Able to manage a team to ensure smooth running of projects within the department.

  • Experience in taking a medical device from concept through to launch, including scale-up and transfer to manufacture

  • Leading risk management process to ISO 14971.

Skills:


  • A good working knowledge of Microsoft Word, Excel, powerpoint, and Microsoft projects (preferable)

  • High level of numeracy

  • Communication skills including written and presentational

  • Excellent attention to detail

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