Medical Device Validation Manager / Engineer

Salary: £31,200 – £33,600 per year

Medical Device Validation Manager
Homebased
6 months contract with possible extension / permanent position, part time
£Competitive

Opportunity:

An up-and-coming medical device company in the field of medical imaging is approaching completion of prototype development and now need an experienced Medical Device Validation Manager to lead and oversee design verification and validation activities required for regulatory submissions.

Your role as a Medical Device Validation Manager will include:

* Contribute to, review and approval of design inputs.

* Preparation of an efficient V&V plan at system and sub-system level.

* Management of activities of the internal project team and external partners, recommending an optimum balance of internal and external tasks.

* Writing, reviewing and approving verification and validation protocols and reports.

* Delivery of bench and V&V test reports according to plans in support of regulatory submissions.

* Monitoring progress and making recommendations for corrective actions where needed to keep the project on track.

* Organisation, oversight and day-to-day management of V&V tasks.

* Contribute to formal design and milestone review processes.

This is an exciting time to join a company that is preparing for approval and launch of its first product. As a key member of a small, highly motivated and experienced internal core team in a dynamic environment you will have both a hands-on operational role and overall responsibility for V&V strategy, planning and delivery.

Initially a 6 month contract, we expect this may be extended or convert to a permanent role which, for the right candidate, we offer a competitive salary, pension contribution, private healthcare and company share options.

Education and Experience:

Essential

* Educated to at least degree level in a technical discipline (scientific / engineering / computing /maths).

* Minimum 5 years working on design verification and validation of electronic medical devices incorporating software, with domain expertise in 510(k) V&V requirements.

* Knowledge of appropriate quality and regulatory requirements in Europe and the USA, especially ISO 13485, ISO 14971, ISO, 21CFR Part 820.

* Knowledge of usability engineering / human factors.

* Experience working with medical device regulatory requirements, design control, change control, and risk management.

* Experience of successful 510(k) submissions.

* Comfortable working with and managing third party organisations for delivery of V&V testing.

Desirable

* Knowledge and experience of devices for medical imaging, ideally gamma, SPECT or PET

* Familiar with Notified Body / CE marking and MDSAP V&V requirements.

* Good network of test labs for bench testing and for V&V testing.

* Notified body / FDA audit experience.