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Senior Manager R&D - Trauma & Orthopaedic Devices

Hlx Life Sciences · Zoug

Nouveau
Senior 🇬🇧 English
ISO 13485 ISO 14971 EU MDR FDA regulations Design control

Description du poste

About the role

Hlx Life Sciences is recruiting, on behalf of a client, a Senior Manager R&D for an international medical device company specialising in trauma and orthopaedic solutions. In this leadership role you will shape the product development strategy, lead high-performing engineering teams and bring new products to market that help surgeons and patients worldwide.

Key responsibilities

  • Lead, develop and inspire a multidisciplinary R&D team of engineers, project leads and technical specialists, directly or through team leads.
  • Set the R&D roadmap with Marketing, Clinical, Regulatory Affairs and Operations, aligned with business strategy and market needs.
  • Oversee the development of trauma and orthopaedic products such as implants, instruments and related systems, from concept to commercial launch.
  • Ensure development follows design control requirements under ISO 13485, ISO 14971, EU MDR and FDA regulations.
  • Manage project portfolios, budgets, resources and timelines to deliver on time and on target.
  • Build relationships with key opinion leaders and surgeons so clinical insight shapes product design.
  • Support regulatory submissions, audits and notified body interactions as needed.
  • Work with suppliers, development partners and manufacturing sites to ensure smooth design transfer.
  • Represent R&D in leadership meetings and contribute to overall business decisions.

Required profile

  • Degree in Mechanical Engineering, Biomedical Engineering or a related field; a Master's or PhD is a plus.
  • 10+ years of experience in medical device R&D, with a strong background in trauma, orthopaedics, spine or similar implant-based technologies.
  • 5+ years of proven people leadership, including building and managing engineering teams.
  • Track record of successfully bringing medical devices to market.
  • Fluent English; additional languages are an advantage.

Required skills

  • Thorough knowledge of medical device regulations and quality standards (ISO 13485, ISO 14971, EU MDR, FDA)
  • Strong strategic thinking combined with a hands-on, results-driven approach
  • Excellent communication and stakeholder management skills, with confidence working with surgeons and senior leadership

What we offer

  • A key leadership position with real influence on the product pipeline and company direction
  • The chance to work on technologies that improve patient mobility and quality of life
  • An international, collaborative and innovation-driven environment
  • Attractive compensation and benefits package
  • Long-term career development opportunities

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