Associate Director (Medical Devices)

Associate Director (Medical Devices)

£75,000 + Excellent Benefits

Cheshire

gap technical are proud to be representing this global manufacturing business in their search for a Associate Director (Medical Devices) to work at their facility based near Cheshire.

Performance Objectives

* To support Global R&D device development activities.
* To provide input to the Device Technology landscape.
* To support Device Design activities.
* To provide technical support to define and continuously improve Business Development activities.
* To manage relationships with contract manufacturing companies, machine and equipment suppliers and specialist test houses.
* To remain informed of and evaluate new manufacturing technology appropriate for the current and future pipeline.
* To support due diligence activities of higher barrier value creation product opportunities, new product acquisitions that may be added to further the sterile pipeline.

Person Specification

* Graduate in Engineering, Physics or similar;
* Post graduate education in Product Development, Business, Manufacturing, Medical Device Regulations would be desirable;
* Knowledge of Device quality management systems (in accordance with ISO13485 and 21CFR 820)
* Experience in managing Device development projects – ideally from concept to launch;
* Knowledge of the regulatory requirements for devices for the US and EU; including the compilation of Design History Files and Design Master Records;
* Experience in design reliability and robustness assessment;
* Proficient in 3D CAD, technical drawings and drawing control;
* Experience in utilising Electromechanical vendors would be desirable;
* In-depth knowledge (through practical experience) of GMP, EU and FDA regulatory requirements;
* Design for development and manufacture – functional and assembly;
* Understanding of device development and manufacturing processes;
* Understanding of device and drug/device combination regulatory requirements;
* Sterile product development knowledge (through experience).

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This vacancy is being advertised on behalf of gap technical who are operating as an employment agency.

gap technical are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability or the job.