Product Development Director

1 month ago


England, United Kingdom Michael Page Full time

Head of Product Development based in North Yorkshire. 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. 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.
* 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.
* Familiarity of applicable EU Medical Device Regulations, e.g., Experience of building projects with collaborators and customers.
ISO13485 Medical Devices.
* ISO14971 Medical Devices Risk Management Assessment.
* Electronics Engineering - ISO60601 Medical electrical equipment.
* Software Engineering - ISO62304 Medical device software. Medical device software in accordance with IEC 62304 and FDA guidance.
*


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