Product Development Manager

45000.00 - 55000.00 GBP Annual + competitive
16 Nov 2016
01 Dec 2016
Contract Type
Full Time
An innovative Medical-Device Start-up, developing an entirely new technology for Medical-Imaging are seeking a Product Development Manager to join their team on a permanent basis.

As a Product Development Manager, you will take on responsibility for Design Control activities, including management of sub-contracted manufacturing partners, test houses and other suppliers, to ensure ongoing compliance with applicable medical device regulations standards while gaining certification for new products and territories.

The role will involve travelling throughout the South of the UK to support the company's clinical and commercial system and product development activities, as well as offering the occasional chance for international travel.

As a Product Development Manager, you will manage the Company's approved suppliers, including sub-contract manufacturing partners, conduct supplier audits, coordinate testing of Company product (e.g. EMC, ISTA) and initiating, managing and submitting design projects for both existing and new Technical Files.

You will also support the Quality Manager by helping in gaining regulatory approval for the Company's products in new markets, including the USA.

Other responsibilities will involve managing budgets related to production and NPI activities and managing the Company's service engineering capability, including Field Service Engineers.

As a Product Development Manager, you will have experience in some of the following areas:

* Proficient in the application of EU medical device regulations and related international standards including: ISO13485, Medical Device Directive, Medical Device Regulation, ISO14971. Also technical standards, including IEC60601 and IEC62304.

* Experience of FDA design controls highly desired

* Demonstrable experience in establishing and successfully managing Design Projects for novel medical devices (ideally up to at least Class IIb)


* Familiarity with radio frequency technologies highly desirable
* Supplier audit training highly desirable
* Proficiency with CAD (e.g. Solidworks or Solid Edge) desirable

If you would like to express interest, please get in touch with a copy of your latest CV, detailing your experience within the relevant areas and call in for Alex Douglas, Consultant, to discuss in more detail