Skånestor AB

Development Engineer – BONESUPPORT Come and join BONESUPPORT as Development Engineer! This is an opportunity to take an active role in the design and development of innovative medical devices, from early concepts to finalized products and manufacturing. BONESUPPORT is an innovative and growing medical device company based in Lund, Sweden. The company develops and commercializes injectable bio-ceramic bone graft substitutes for the treatment of bone disorders. To further strengthen our Development & Engineering department, we are now looking for a Development Engineer with a strong technical background and hands-on experience in mechanical design, product development and verification. Your role As Development Engineer, you will be involved in the development of new medical devices as well as improvements to existing products. You will work throughout the product development process, from concept development and mechanical design to verification, validation and transfer to manufacturing. The role has a strong technical focus, combining hands-on mechanical engineering and CAD design with testing, material selection and manufacturing considerations. You will be responsible for developing robust technical solutions that meet functional requirements and can be efficiently manufactured. You will work closely with colleagues within R&D, Operations, Quality Assurance and Regulatory Affairs, as well as external suppliers and manufacturing partners. Your main responsibilities will include: Design and develop medical device components and assemblies using 3D CAD tools. Execute design activities through all product development phases. Create and maintain engineering drawings, technical specifications and design documentation. Perform mechanical design activities, including material selection, tolerance analysis and component optimization. Develop technical solutions with consideration for Design for Manufacturing (DFM), Design for Assembly (DFA) and Design for Reliability. Collaborate with suppliers and manufacturing partners on tooling, injection molding and manufacturing optimization. Develop, plan and perform verification and validation testing. Establish test methods and prepare test protocols and reports. Analyze test results, identify potential improvements and provide recommendations for design modifications. Participate in design reviews, risk management activities and cross-functional development projects. Support design transfer activities and contribute to design control documentation in accordance with applicable regulatory requirements. Qualifications We are looking for a technically skilled engineer with practical experience in mechanical design and product development within the medical device industry. To succeed in this role, we believe you have: A technical academic background at Bachelor's level or higher, preferably in Mechanical Engineering or a related field. Relevant experience in mechanical design and product development within the medical device industry. Hands-on experience with 3D CAD software, such as SolidWorks, Inventor or similar. Experience in creating engineering drawings, technical specifications and detailed design documentation. Good understanding of materials, manufacturing processes and mechanical design principles. Experience in planning, performing and documenting design verification activities, including test methods, protocols and reports for mechanical and functional testing. Knowledge of Design for Manufacturing (DFM), Design for Assembly (DFA) and tolerance analysis. Ability to analyze technical problems, evaluate test results and develop practical engineering solutions. Good technical writing and documentation skills. Preferred qualifications It is an advantage if you also have experience or knowledge in: Injection molding, tooling and component manufacturing. Design Control and requirements management. Risk management according to ISO 14971. Usability engineering according to IEC 62366. Medical device safety standards. Implantable medical devices. Statistical methods and test method development. Design transfer and collaboration with external manufacturing partners. Personal qualities We believe you are analytical, structured and solution-oriented, with a strong interest in technical problem-solving and product development. You enjoy working hands-on with engineering challenges and have the ability to translate technical requirements into practical and reliable design solutions. You take ownership of your tasks, work independently and proactively drive activities forward. At the same time, you value collaboration and enjoy working with colleagues from different technical and functional backgrounds. You are comfortable working in an environment where technical challenges require both attention to detail and an understanding of the complete product development process. Why BONESUPPORT? At BONESUPPORT, you will have the opportunity to contribute to the development of innovative medical devices that make a difference for patients. You will join a growing company where product development, engineering and manufacturing expertise come together. The position offers an opportunity to take an active role in technical development projects and contribute to the continued development of BONESUPPORT's products. Location: Lund, Sweden Application SKÅNESTOR is managing the recruitment process on behalf of BONESUPPORT. Please apply directly through this advertisement. For questions, please contact SKÅNESTOR at maria.gren@skanestor.se.

Come and join BONESUPPORT as Design Control Engineer! This is an opportunity to apply your expertise in design control, risk management and technical documentation, contributing to the continued development and lifecycle management of innovative medical devices. About BONESUPPORT BONESUPPORT™ AB is an innovative and growing medical device company based in Lund, Sweden. The company develops and commercializes injectable bio-ceramic bone graft substitutes for the treatment of bone disorders. BONESUPPORT's products are based on its patented CERAMENT® technology platform, with the aim of improving treatment outcomes for patients. About the role As Design Control Engineer, you will join the Development & Engineering department and play an important role in product lifecycle management, with a focus on design control, change control and risk management. You will contribute to maintaining and developing the technical documentation for BONESUPPORT's products, ensuring compliance with applicable regulatory requirements, standards and internal procedures throughout the product lifecycle. Risk management is an important part of the role, and you will have the opportunity to contribute your knowledge and experience to further strengthen this area within the organization. Your main responsibilities will include: Manage and support design control and change control activities for existing products and product improvements. Prepare, review and maintain technical documentation, including design and development documentation. Participate in risk management activities, including risk assessments and FMEA, in accordance with ISO 14971. Plan, conduct and document verification and validation activities. Support requirements management and maintain traceability between requirements, risks and verification activities. Contribute to usability engineering activities in accordance with applicable standards. Perform gap analyses related to updated regulatory requirements, standards and guidelines. Develop and maintain technical procedures, specifications and other quality system documentation. Collaborate with cross-functional teams to support product changes, investigations and continuous improvements. You will work closely with Quality Assurance, Regulatory Affairs, R&D, Operations and other functions, as well as external partners. Qualifications We are looking for a structured and motivated engineer with practical experience in design control and technical documentation within the medical device industry. To succeed in this role, we believe you have: A technical academic background at Bachelor's level or higher. Relevant experience from the medical device industry. Hands-on experience with design control, change control and technical documentation. Experience in requirements management and design verification activities. Knowledge of risk management according to ISO 14971, including FMEA and risk management documentation. Knowledge in Usability engineering according to IEC 62366. Good understanding of applicable medical device regulations and standards (EU and US). Strong technical writing and documentation skills. Preferred qualifications It is an advantage if you also have experience or knowledge in: Implantable medical devices. Sterilization processes. Statistical methods and test method development. Personal qualities We believe you are structured, analytical and detail-oriented, with a practical and solution-focused approach to your work. You are comfortable taking responsibility for your tasks and driving activities forward independently, while recognizing the importance of collaboration and knowledge sharing. You communicate clearly, take initiative and enjoy working with colleagues from different functions. You are motivated by continuous improvement and contributing to the development of both products and processes. Why BONESUPPORT? At BONESUPPORT, you will have the opportunity to work with innovative medical devices that make a difference for patients. You will join a growing company with dedicated colleagues and a collaborative working environment. The role offers an opportunity to apply and further develop your expertise in design control and risk management while contributing to the continued development and maintenance of BONESUPPORT's products. Location: Lund, Sweden Application SKÅNESTOR is managing the recruitment process on behalf of BONESUPPORT. Please apply directly through this advertisement. For questions, please contact SKÅNESTOR at maria.gren@skanestor.se.