Director Development & Engineering Jobs

Cerament (Bonesupport)

Location:
Sweden, Lund

Category:
Research and Development

Contract Type:
Not provided

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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Director Development & Engineering