Head of Research And Development

vor 1 Woche

Hamburg, Hamburg, Deutschland Meet Life Sciences Vollzeit

Head of R&D – Medical Devices (Class II and Class III)

We are supporting a confidential medical device manufacturer that is seeking an experienced
Head of R&D
to lead product development across a portfolio of regulated Class II and Class III medical devices.

This position is suitable only for senior professionals with a strong background in regulated medical device development and leadership.

As Head of R&D, you will take full ownership of technical strategy, development delivery, and team leadership across multidisciplinary engineering teams. You will work closely with Quality, Regulatory, Clinical and Manufacturing leaders to ensure products are developed in line with regulatory requirements, business objectives and patient safety standards.

Key responsibilities

  • Lead cross functional R&D teams across software, electronics, mechanical and systems engineering
  • Own the R&D strategy, development roadmap and portfolio execution
  • Ensure compliance with MDR, ISO 13485 and FDA design control requirements
  • Drive development from concept through verification, validation and transfer to manufacturing
  • Partner closely with Quality and Regulatory leaders through development and submissions
  • Lead risk management activities including design FMEA and hazard analysis
  • Support audits, inspections and notified body interactions
  • Provide technical leadership on design decisions and complex problem solving
  • Contribute to long term product and technology strategy

Requirements

  • 12 plus years' experience in medical device R&D
  • Demonstrated leadership of Class II and Class III devices
  • Experience working within MDR, ISO 13485 and FDA environments
  • Proven success leading multidisciplinary engineering teams
  • Strong understanding of risk management and design controls
  • Experience supporting regulatory submissions and audits
  • Fluency in German and English is essential

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