Design Control Engineer - Bonesupport (lund)
Toblor Consulting AB / Sjukhusteknikerjobb / Lund
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hela Sverige BONESUPPORT (Nasdaq Stockholm: BONEX) 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 company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 329 million in 2022. Please visit
www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
Come and join BONESUPPORT as Design Control Engineer! Here is a chance to contribute with your experience in an agile and creative company with extraordinary products!
BONESUPPORT is an innovative and rapidly growing orthobiologics company, based in Lund, Sweden. To further strengthen the company, BONESUPPORT is now looking for an experienced and driven Design Control Engineer to be a part of our company.
Your role
You will work with Product Lifecycle management of BONESUPPORT's products, where the focus will be on the processes of design control/change control.
You will be responsible for that the products are in compliance with the regulatory requirements including also compliance with up-dated standards, guidelines and regulations throughout the lifecycle of the products by up-dating, reviewing and establishing engineering documents and Standard Operation Procedures according to the regulatory requirements. In this position, you will also manage material specifications from suppliers, lead risk assessments (FMECA) with multi-functional teams and perform different type of gap-analyses.
In your role as Design Control Engineer in the Development & Engineering department, you will collaborate closely with Quality, Regulatory, Research and Operations as well as with external partners.
Qualifications
For this position, we are looking for a person with the following experience and qualifications:
• Technical academic background on a bachelor level or higher
• At least four years' relevant experience from the medical device industry
• "Hands on" experience of medical device, technical documentation (design control documentation)
• Medical Device Regulation (MDR 2017/745) experience preferred along with a solid working knowledge of FDA Quality System Regulations and ISO 13485.
• Experience of driving and documenting design control activities such as requirement engineering, labeling and design verifications in new product development
• Knowledge in statistical methods, risk management ISO 14971 and usability engineering (IEC 62366)
• Experience in leading the creation of design and development documentation to support the regulatory files and to support clinical studies according to FDA, ISO and MDR
It will be seen as a merit if you have knowledge and experience in class III implant products and sterilization processes.
At BONESUPPORT we 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 Lifecycle Management. You need to be fluent in English and it is an advantage if you also read and speak Swedish/Scandinavian.
BONESUPPORT offers
At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance. We believe in our journey and take pride in what we do! You will contribute to making life easier for many people around the world.
Information and application
For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR's career site,
https://career.toblor.se/, by uploading your CV and personal letter.
We are looking forward to seeing your application!
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-11-01
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Toblor Consulting AB (org.nr 559244-5547),
http://www.toblor.se Arbetsplats Toblor Consulting
Kontakt Tobias Lorentzon
tobias@toblor.se 0735-11 10 60 Jobbnummer 7777877
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