Head of Product and Systems Development.
Salary: �70,000 - �75,000 per annum DOE
Employment Type: Full time, Permanent
Location: Sedgefield
We are seeking a Head of Product and Systems Development to lead and inspire a dynamic team in delivering technical excellence across a range of ISO certified MedTech fields. Your primary responsibility will be to oversee the design, development, and implementation of innovative end-to-end products and systems that exceed customer expectations. This pivotal role involves crafting a systems strategy to consistently deliver state-of-the-art solutions within the MedTech ecosystem.
Key Responsibilities:
� Develop and refine functional strategy for advanced systems engineering, ensuring scalability as the business grows.
� Design and manage solution engineering tailored to specific client and business needs, providing essential infrastructure and services.
� Lead multiple projects throughout the full lifecycle of products and systems development, from conception to delivery.
� Ensure the delivery of customer-focused features, product quality, reliability, regulatory compliance, and cost-effectiveness.
� Collaborate with Bid Development teams to define technical elements of bids and engage in customer engagement.
� Identify and pursue business development opportunities, contributing to proposal construction and content.
� Provide specifications for solution definition, management, and delivery.
� Coordinate across technical functions to optimise solutions and streamline processes.
� Drive continuous improvement of cross-functional processes within engineering and sciences teams.
Requirements:
� Degree in Science or Engineering; advanced qualifications preferred.
� Strong leadership skills with experience in leading technical teams.
� Proven track record of integrating hardware, software, and other elements in multidisciplinary system designs.
� In-depth technical knowledge and authority in Systems Engineering.
� Ability to translate customer needs into actionable specifications for the development team.
� Experience in the medical device industry and working in ISO13485 operational environments.
� Familiarity with EU Medical Device Regulations (e.g., MDR, IVDR) and ISO14971 Medical Devices Risk Management Assessment.
� Experience in direct and indirect line management, representation at customer meetings and conferences, and project collaboration.
� Additional qualifications in ISO13485 Medical Devices, ISO60601 Medical electrical equipment, and ISO62304 Medical device software are advantageous.
� Working knowledge of medical device software development standards (IEC 62304, FDA guidance), supporting marketed products, and device clinical trials.
If you are a visionary leader with a passion for driving innovation in HealthTech, we encourage you to apply.