Head of Product Development based in North Yorkshire. Working for a well established R&D Organisation

Client Details

Our client is a well established R&D Organisation based in North Yorkshire

Description

We are looking for a Head of Product and Systems Development to deliver technical excellence by leading and developing a multi-disciplinary team to design, develop and implement a range of endto-end products and systems in a variety of ISO certified HealthTech fields that delight our customers. This includes developing a systems strategy that can be applied to the HealthTech ecosystems to consistently provide state of the art innovative solutions.

Key tasks in the role will include

* To drive functional strategy to advanced systems engineering through processes and design practices and to further develop and define the future structure of the technical team to be scalable as the business grows.

* To design, describe, and manage solution engineering to match with specific client and business problems providing the core infrastructure(s) and services.

* To lead multiple projects, both in engineering and science activities throughout the products and systems development full lifecycle.

* To deliver customer feature functionality, product quality, reliability, serviceability, manufacturability, regulatory, compliance, and cost.

* To act as a credible partner to Bid Development teams, actively involved in defining and advising on the technical elements of bids, in order to develop a programme of works and direct customer engagement.

* Seek out and engage in business development opportunities where appropriate, providing critique, approval, construction and content of proposals.

* To provide specifications according to which the solution is defined, managed, and delivered.

* To coordinate across technical functions to provide the optimum solution.

* To improving the cross-functional processes within the engineering and sciences teams, striving for high level of efficiency and effectiveness in execution.

Profile

It is essential that you are educated to degree level (or equivalent) in a Science or Engineering subject. It is also essential that you:

* Have strong leadership capabilities of leading a team of technical experts.

* Can demonstrate evidence of building and managing teams that integrate hardware, software, firmware, people, information, techniques, facilities, services, and other support elements in multidisciplinary system designs.

* Actively demonstrates in-depth technical knowledge in systems development and is viewed as an authority in Systems Engineering by peers and managers.

* Can evidence the ability to elicit and translate customer needs into specifications that can be realised by the system development team.

* Experience working in a medical device industry.

* Working to and experience of an ISO13485 operational environment.

* Familiarity of applicable EU Medical Device Regulations, e.g., MDR, IVDR.

* Experience of direct and indirect line management.

* Representation of the company at customer meetings and conferences.

* Experience of building projects with collaborators and customers.

It would be great if you were also qualified in:

* ISO13485 Medical Devices.

* ISO14971 Medical Devices Risk Management Assessment.

* Electronics Engineering - ISO60601 Medical electrical equipment.

* Software Engineering - ISO62304 Medical device software. Alongside:

* Medical device software in accordance with IEC 62304 and FDA guidance.

* Supporting marketed products.

* A working knowledge of device clinical trials (from the device perspective)

Job Offer

£70,000 to £78,000 plus benefits