Development Manger

ISL Recruitment
Birmingham, West Midlands
10 Jun 2017
10 Jul 2017
Contract Type
Full Time
*Development Manager* FDA* ISO* IEC62304* Software Development* software* mechanical *electronics *Management* Engineering*

Location- Birmingham.
Salary - £65,000

A dynamic and fast-growing company with in the midlands is searching for a Development Manager. They have strong presents within the medial field and are looking for someone to continue to drive the commercial introduction if their cutting-edge products. The package includes a generous salary and the chance to work in with a top company within their field.

This is a chance not to be missed!

Development Managers Role

You will be in required to lead the Project Team and manage a group of engineers. You will also work closely with the Technical Director to ensure that the projects align with the requirements of the business.

The Development Manager will lead the day to day development of new medical equipment, this includes being in control of all development stages from defining requirements, design, testing, documentation and handover to manufacturing.

Development Managers Responsibilities

*Ensure that all Technical File documents to the Notified Body and FDA are compliant.
*The development manager will be required to lead a team of technical specialists (software, mechanical and electronics).
*Create plans and actively manage resources to deliver projects to the agreed time and costs requirements.
*Ownership of the bill of materials / costs during the development phases.
*Communicate issues in a clear and timely manner and where necessary seek support to ensure successful project outcomes.
*Ensure the needs of all users are met and that these are tested at key stages of development.
*Delivery within the requirements of the ISO13485 Quality Management System.

Key Knowledge & Required Skills

*At least two years experience in a similar role, with proven track record of; delivering projects on time, communicating and liaising and resolving project issues to ensure success within projects.
*Ability to lead projects within cost and time frames, spanning engineers, commercial, clinical and regulatory disciplines.
*Previous experience working with accredited test houses and notified bodies to achieve CE and FDA approval.
*Achieving regulatory compliance to relevant standards, in particular overseeing design and testing to the requirements of IEC 60601-1 (third edition), IEC 60601-1-2 (fourth edition), ISO 14971, IEC 62366.
*Good understanding of delivery of software projects and the specific requirements of IEC62304.
*Ability to manage external manufacturers, suppliers of components and sub-assemblies.
*Excellent verbal and written communication skills with strong sense of ownership and ability to draft high quality technical documents to support regulatory submission.
*A recognised project management qualification is desirable.
*Degree qualified in a related engineering discipline preferred.
*Ability to travel domestically and internationally if and when required.
*Must have a current and valid UK / European driving licence.

If you are the person to support this company's success with passion, ambition and experience speak to Imogen.

Interview slots are available from 12th so submit applications now to get secure an interview.

*Development Manager* FDA* ISO* IEC62304* Software Development* software* mechanical *electronics *Management* Engineering*

ISL (Incite Solutions Ltd) is acting as an Employment Agency in relation to this vacancy.