Product Development Director

2 months ago


Sedgefield, Durham, United Kingdom CDM Recruitment Full time
Head of Product and Systems Development

We are seeking a visionary leader to drive innovation in HealthTech as the Head of Product and Systems Development. This pivotal role involves crafting a systems strategy to consistently deliver state-of-the-art solutions within the MedTech ecosystem.

Key Responsibilities:
  1. Develop and refine functional strategy for advanced systems engineering, ensuring scalability as the business grows.
  2. Design and manage solution engineering tailored to specific client and business needs, providing essential infrastructure and services.
  3. Lead multiple projects throughout the full lifecycle of products and systems development, from conception to delivery.
  4. Ensure the delivery of customer-focused features, product quality, reliability, regulatory compliance, and cost-effectiveness.
  5. Collaborate with Bid Development teams to define technical elements of bids and engage in customer engagement.
  6. Identify and pursue business development opportunities, contributing to proposal construction and content.
  7. Provide specifications for solution definition, management, and delivery.
  8. Coordinate across technical functions to optimise solutions and streamline processes.
  9. Drive continuous improvement of cross-functional processes within engineering and sciences teams.
Requirements:
  1. Degree in Science or Engineering; advanced qualifications preferred.
  2. Strong leadership skills with experience in leading technical teams.
  3. Proven track record of integrating hardware, software, and other elements in multidisciplinary system designs.
  4. In-depth technical knowledge and authority in Systems Engineering.
  5. Ability to translate customer needs into actionable specifications for the development team.
  6. Experience in the medical device industry and working in ISO13485 operational environments.
  7. Familiarity with EU Medical Device Regulations (e.g., MDR, IVDR) and ISO14971 Medical Devices Risk Management Assessment.
  8. Experience in direct and indirect line management, representation at customer meetings and conferences, and project collaboration.
  9. Additional qualifications in ISO13485 Medical Devices, ISO60601 Medical electrical equipment, and ISO62304 Medical device software are advantageous.
  10. Working knowledge of medical device software development standards (IEC 62304, FDA guidance), supporting marketed products, and device clinical trials.


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