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Director Development & Engineering

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Cerament (Bonesupport)

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Location:
Sweden , Lund

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

BONESUPPORT ™ AB is a leading Scandinavian biotechnology company based in Lund, Sweden. BONESUPPORT ™ AB aims to become a global leader in orthobiologics by optimizing bone biology to treat bone disorders. BONESUPPORT ™ AB develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The vision of the Development & Engineering organization is to efficiently take concepts through the product development process, ensure lifecycle management matching regulatory and competitive requirements and facility well managed design transfers of new products into Operations. As the Director Development & Engineering, you are responsible to ensure product lifecycle management of current commercial products and for the development of new products in line with company strategy. The team is in addition responsible for technical documentation, verifications and validation activities, risk management, usability, labelling and sterilization activities. You will lead a very professional team of six senior individuals, with strong competencies within design control, design & engineering, biological safety and risk management. Hands-on assignments will also be a part of the daily work.

Job Responsibility:

  • Overall responsibility for Design Controls, Risk Management, Usability Engineering and Change Controls
  • Lead and motivate the Development team to achieve its objectives and being a high performing team
  • Structure, plan and lead the work within Development & Engineering
  • Ensuring product lifecycle management of current product
  • Responsible for changes required for commercial products
  • Development of new products in line with company strategy
  • Collaborate tightly with other core functions

Requirements:

  • M.Sc. degree within engineering or chemistry
  • Minimum 8 years relevant experience in medical device and/or pharma
  • Proven leadership and management experience
  • Experience with medical devices class II and class III preferred
  • Experience with medical device combination products preferred
  • Experience with taking medical devices through the development pipeline according to design control requirements for CE marking and/or FDA approval
  • Experience in Design transfer / implementation of a new products in Manufacturing
  • Experience from working with lifecycle management of product portfolio
  • Experience from and understanding of design control, risk management, CAPA investigation, labelling, requirements, and qualification/validation documentation at a level adequate for regulatory submissions Notified Body / FDA

Nice to have:

  • Experience from leadership and working with medical device and preferably products with active substances
  • Worked with development / engineering of products and has an understanding of the end-to-end process of medical device product development/lifecycle management
  • Driven by developing others and creating well performing teams
What we offer:
  • Dynamic and stimulating workplace
  • Great teamwork, innovation, passion, and performance

Additional Information:

Job Posted:
December 07, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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