BONESUPPORT AB (Nasdaq Stockholm: BONEX) is a rapidly growing orthobiologics company which develops and commercializes innovative injectable bioceramic 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.

Our commercial products

CERAMENT® BONE VOID FILLER
CERAMENT® G
CERAMENT® V

deliver important clinical benefits to patients and surgeons due to their ability to remodel to the patient’s own bone and to elute antibiotics directly into the bone void to protect the healing process. These products target a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver.

The Company is also developing a pipeline of new product candidates that have the potential to treat additional important indications based on their ability to promote bone growth.

Sustainability is an essential aspect of everything we do. Our aim is to engage all our leaders and employees in our journey to embed environmental, social, and governance considerations into our daily operations. To achieve this, we have a clear vision and strategy that includes collaborative work in global, cross-functional teams, with a strong commitment to diversity and inclusion.

BONESUPPORT has around 130 employees and almost half of them are based in Lund at the company headquarters.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB. The net sales amounted to SEK 591 million in 2023.

For more information, please see www.bonesupport.com

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Mechanical Engineer in Medical Device


Company: BONESUPPORT
Position: Mechanical Engineer in Medical Device
Reports to: Director Development & Engineering, Head of Program Office
Location: Lund, Sweden


Vision – Becoming a global orthobiologics leader, optimizing bone biology for the treatment of bone disorders.
Mission – Restoring health to improve the quality of life for patients with bone disorders.


BONESUPPORT is now looking for an experienced and driven Mechanical Engineer to be a part of the company! 
 
About the job  


The position as Mechanical Engineer is an exciting opportunity to be part of the further development of BONESUPPORT's products, improvement of manufacturing processes and launch of new products on the market. This is a key role for the company to build internal competence in this important area of knowledge. 
 
You will work with product development of BONESUPPORT’s products, where the focus will be on new product development. Here you will have a key role in the companies’ mission to improve the quality of life for patients with bone disorders. You will be responsible for the technical design of medical devices from concept through product design and manufacturing from a user centric and design for manufacturing point of view. In addition, you will develop test methods for design verifications and simulated use validation to ensure safe and effective use of medical devices. Your work needs to be documented according to regulations, standards and industry best practice under design control. You need to be fluent in English and it is an advantage if you also read and speak Swedish/Scandinavian. 
 
Much of the work will focus on engineering documentation such as drawings, change orders, risk analyses, bill of materials and validation documents to meet all requirements. Tasks also include interaction with suppliers, customers and test houses. 
 
In your role as Mechanical Engineer in the Development & Engineering department, you will be part of the core teams for new development projects, and therefore collaborate closely with Project Managers, Research, Operations and QA/RA as well as with external partners.  
 
At BONESUPPORT they value personal skills as much as professional qualifications, and in this role, we are looking for a dedicated and self-driven person with great collaboration skills who also have a genuine interest in medical device and product development. You need to be innovative and have a creative mindset with a problem-solving attitude as well as being flexible and able to adjust to current conditions. 
 
You will be located at BONESUPPORT headquarter in Lund and report to the Director Development & Engineering, Head of Program Office. 
 

Job responsibilities  
 
• Responsible for the technical development of medical devices from idea to product design and manufacturing 
• CAD and modeling 
• Develop test methods for design verifications and validations to ensure the safe and effective use of medical devices 
• Responsible for identifying and proposing production methods and material selection in consultation with Operations; from research through the design phase and into running production regarding design, investments, time plan, material selections, etc. 
• Document according to regulations, standards and industry best practice under Design Control 
• Participate in risk analyses and other documentation such as drawings, design history files, change orders, bills of materials, test protocols, reports and validation documents to meet all requirements (quality, reliability, manufacturing, regulatory, cost, etc) 
• Participate in user tests and follow-up on customer feedback on potential device failures 
• Identify problems and develop new solutions 
• Pro-active stakeholder management - close collaboration with Project Managers, Research, Operations and QA/RA as well as with external partners such as suppliers, consultants and test houses 
 

Education, experience and qualifications 
 
• B.Sc. or M.Sc. engineering degree or similar technical background with focus in Mechanical, Plastics or Biomedical Engineering 
• At least three years’ experience from the medical device industry 
• “Hands on” experience of medical device projects, from ideation, concepting until development and high-volume production – an advantage 
• Strong knowledge of materials, functional product design, design for manufacturing and prototyping skills 
• Experience from CAD and modeling 
• Good knowledge of injection molding – an advantage 
• Familiar with Good Documentation Practice, Design Control and ISO 13485 / FDA Quality System Regulations requirements 
• Experience from working with cross-functional and global teams  
• Fluency in English (spoken/written) 
• Experienced user of MS Office package 
 


Required skills and personal characteristics 

 • Deciding and initiating action; makes prompt, clear decisions which may involve tough choices or considered risks. Initiates and generates actively and works under own direction. 
• Working with people; demonstrates an interest in and understanding of others; Listens, consults others and communicates proactively 
• Analysing; analyses numerical and verbal data and all other sources of information. Produces workable solutions to a range of problems. 
• Creating and innovating; produces new ideas, approaches or insights. Devises effective change initiatives.  
• Adapting and responding to change; ability to adapt to changing conditions and accepts new ideas and change initiatives 
 
 
Opportunities with the role 
 
Here is a chance to contribute with your experience in an agile and creative company with extraordinary products! 
 
At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. The company offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance. They believe in their journey and take pride in what they do! 
 
The Mission is clear "Restoring health to improve the quality of life for patients with bone disorders." and BONESUPPORT wants you to be a part of the journey. Here is an opportunity to contribute with your experience in an agile and creative company with extraordinary products, come and join BONESUPPORT as Mechanical Engineer! 


Contact

For inquires and more information about the position, please contact:

Catharina Herbertsson or Eva Runnerström, Senior Recruitment Consultants at PeakSearch.

E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379


Application
Apply for the position at www.peaksearch.se