Biocompatibility specialist
Atos Medical AB / Civilingenjörsjobb / Hörby
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Do you want to make a difference for people breathing, speaking, and living with a neck stoma? Do you have keen interest in the field of Biocompatibiltiy/Biosafety and the regulatory field of medical devices? Do you see structure and logic where others see chaos and bureaucracy?
When you join us, you will be making a difference every single day!
About the role
Atos are emphasizing more on the field of biocompatibility of our products to meet the demands and to comply with the regulations. Our products are introduced in new countries and markets at the same time as products with current registrations, in 60+ countries, needs to be maintained.
You will be joining a team with 13 colleagues who all have different background and competencies and together we are the "Sustaining Engineering Team" which is a part of Quality Assurance. In our team we are handling our technical files, change orders, complaints, process validations and labelling.
You will work closely together with the team in Sustaining Engineering as well as Supply, R&D and other departments. You will also be responsible for contact with device testing companies and consultants. You will have the overall responsibility for the compilation of bio documents of the devices.
The Sustaining Engineering team is based out of Hörby in Sweden, so if you live and work in the area, that is of course a plus, but we do apply a hybrid model of working where multiple sites may be used. Hörby and Hyllie in Malmö and your private home are main alternatives. We are looking to fill a full-time position.
Your responsibilities
• Independently drive biocompatibility issues of all active products on the market.
• Identify the need for tests being made on products.
• Coordinate biocompatibility testing towards test companies.
• Interpret test results and compile into Bio documentation and suggest improvements.
• Work close in cooperation with the Change owners and validation engineers in Sustaining Engineering.
• Being part of risk analyses on the products.
• Evaluate impact of changes of materials on the biocompatibility.
• Keep the material certificates updated according to the regulatory requirements.
• Keep the team updated on new regulatory demands regarding biocompatibility product safety.
• Update SOPs and working routines connected to biocompatibility evaluation.
• Assist the PMS team with questions regarding materials and biocomp
About you
We are not a very big company so everyone in Atos Medical is truly contributing to our success. You will be our Bio Comp expert and therefore you need to feel comfortable in taking full responsibility of biocompatibility on our existing products.
We are looking for someone experienced with good general chemical knowledge and good documentation skills. You must enjoy working independently with many tasks in parallel and have the ability to prioritize, implement and complete tasks.
We want you to have:
• Master of Science degree or equivalent, in fields such as biocompatibility, chemistry and toxicology.
• Minimum 3 years' experience in the area is desired.
• Experience in working with medical device.
• Material knowledge, primarily polymers, silicones & adhesives
• Knowledge in standards such as ISO13485, ISO10993, MDR, REACH etc.
• Good knowledge in Swedish and English.
• Experience from laboratory work can be a merit.
Does this sound like the perfect challenge for you? Please send your application today, the last day for applying is February 20th, but applications will be reviewed on an ongoing basis.
If you have any questions, or just want more information of the positions, feel free to reach out to Sustaining Engineering Manager, Petter Solding, via e-post:
petter.solding@atosmedical.com About Us
Atos Medical develops and sells medical devices, driven by the desire to make life easier for people living with a neck stoma in over 90 countries.
Since our foundation in 1986, we have cemented ourselves as the leaders in neck stoma care, and today our business includes innovative products in laryngectomy and tracheostomy care to help people breathe, speak, and live well.
We are a truly global organization with Swedish roots made up of about 1200 employees and 25 subsidiaries worldwide. Atos Medical is a part of Coloplast A/S.
For more information, please visit our career page
www.atosmedical.com/about/life-at-atos-medical/ Ersättning Monthly salary
Så ansöker du Sista dag att ansöka är 2023-03-08
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Atos Medical AB (org.nr 556268-7607),
https://www.atosmedical.se Arbetsplats Atos Medical
Jobbnummer 7426491
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