”To bring people with bone and joint diseases back to an active life.”

BONESUPPORT, a Scandinavian medical technology company, is an emerging leader of injectable bone graft substitutes (with the CERAMENT™ platform) for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications.

BONESUPPORT has assembled a strong team of scientists and engineers, and a market leading sales and marketing group to develop and bring an innovative portfolio of products to the spinal and orthopedic market. In collaboration with a number of well-known international universities and hospitals, BONESUPPORT has developed a number of new, patented technologies and applications. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. Total number of employees is 25 whereof 18 in Lund.

BONE SUPPORT’s products
BONESUPPORT has 3 CE marked products today:
• CERAMENT™lBONE VOID FILLER (also FDA cleared)
• CERAMENT™lSPINE SUPPORT
• CERAMENT™lG

CERAMENT™ is an innovative platform of products used to manage bone voids and gaps created by trauma, infection, disease or surgery, vertebral compressions, fractures and osteomyelitis (infection).

CERAMENT™ is a synthetic bone substitute, which mimics natural bone, providing short-term support for fractures and bone voids with rapid pain relief and stabilization, as well as longer-term osteoconductive support that allows for new bone formation within 6 to 12 months.

CERAMENT™lBONE VOID FILLER is intended for orthopedic applications as filler for gaps and voids, whereas CERAMENT™lSPINE SUPPORT is intended for use in the stabilization of vertebral compression fractures in the vertebral body. The newest product is CERAMENT™lG, which contains the antibiotic Gentamicin. CERAMENT™|G is the first injectable bone substitute containing an antibiotic to protect and promote bone healing in the management of osteomyelitis (bone infection).

In Dec 2013 the second antibiotic (vancomycin as antibiotic) loaded CERAMENT product – CERAMENT™lV - was filed to BSI. The launch is expected to be in Jan/Feb 2015.

The vision of BONESUPPORT is to be the world leader in the market for injectable, synthetic ceramic bone substitutes and injection accessories. For more information please see http://www.bonesupport.com.
Design and Development Engineer, Medical Device TILLSATT
The position

We are looking for a person who likes to make things happen, a dedicated person with strong problem solving skills with experience from the Medical Device area. You will be responsible for various change programs ("continuous engineering") needed to be made continually on already approved products.

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 for product changes. You will conduct complaint and CAPA investigations as well as verifications/validations. Work content also includes interaction with suppliers, customers and test houses. You will be responsible for updating the drawings, but not developing them, this is outsourced to another company.

A combination of being a Mechanical Design Engineer (“hands-on person”) and a Project Manager is an advantage, as most of the work needs to be done in a structured way and to meet necessary goals.

You will work in an international team and in close collaboration with the Production Manager (Department Production/Logistics). You will also collaborate with the Marketing and the Quality & Regulatory Departments. You will report directly to the Head of R&D.

Main tasks and responsibilities

• Create and manage engineering documentation such as drawings, design history files, risk analyses, change orders, bills of materials, test protocols, reports and validation documents to meet all requirements (quality, reliability, manufacturing, regulatory, cost etc) for product changes
• Conduct complaint evaluations and CAPA investigations to understand potential device failures
• Plan and lead product development projects and product improvements
• Identify problems and recommend solutions
• Collaborate with suppliers, consultants and test houses

Qualifications and education

• BSc or MSc in Engineering (Mechanical, Medical Device, Biomedical, Material Engineering or related technical field) - or long experience from Medical Device
• Experience in the Medical Device industry
• English and Swedish


Experience and knowledge

• Experience from design & construction within Medical Device
• Experience in bringing results from Research through to Production
• Experience in preparing and implementing validations and verifications
• Experience of packaging, sterilization processes, shelf life studies and transport tests
• Experience in working in a team environment and/or leading cross functional teams in problem solving and continuous improvement - advantage
• Knowledge about plastic materials - advantage
• Experience of using Microsoft Office


Required skills and personal characteristics

• Sets high standards for quality and quantity
• Writes clearly, succinctly and correctly
• Able to organize, plan and implement activities according to established goals
• Being responsible, accurate and flexible
• Being both practical and theoretical
• Can work independently as well as in a team
• Productive even in a high pressure environment

Other

Residence within commuting distance from Lund. You will travel occasionally to e.g. relevant congresses/exhibitions.

Opportunities with the role

BONESUPPORT is an exciting company with a highly engineered product, which has been shown to really make a difference in some patient’s life. People working at BONESUPPORT are very dedicated and proud of what they have accomplished. It is more than just “work”, they feel proud to help patients who are suffering. The company will offer you a responsible and challenging job. The vision of the company -
To bring people with bone and joint diseases back to an active life!

Since BONESUPPORT it is a small company, the members of the R&D team are involved – more or less - in every step, from the initial idea to the final product. The feedback from the clinic is a direct measure of how BONESUPPORT has succeeded.

Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Recruitment Consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0) 706 152772
eva.runnerstrom@peaksearch.se, +46 (0) 701 725379
http://www.peaksearch.se

Application: Apply for the position at http://www.peaksearch.se.