Medical Device Scientist
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Roskilde
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Job Title: Medical Device Scientist
Denmark, Roskilde
Overview
You will report to the R&D manager and be part of the R&D group with 4 scientists and 3 laboratory technicians. Focus areas for the group are development of plastic consumables for cell culture, immunology and bioproduction related applications.
How will you make an impact?
As a Medical Device Scientist, you will be be the “go-to person” for requests from our Operation, QA and RA teams. You will have a central role in supporting QA and RA for Risk Management activities as well as Post-market surveillance activities for the Medical Device products. You will be responsible for creating documents for Design History Files and Risk Management Files to support the development and manufacturing of our medical devices. Central for these activities will be Design Control activities including Biological Evaluation Report for Medical devices (and will involve activities spanning from initiating study reports (internal/external). You will also develop data in the lab and finalize study reports for a range of products.
What will you do?
• Work as part of a multidisciplinary team to determine which technical data are relevant according to ISO standards
• Be the technical driver of Biological Evaluation Reports.
• Plan and execute on experiments, conduct evaluations and interpretation of results and documentation of the completed experiments into the Biological Evaluation Report.
• Be a proactive member on teams executing Product Design Control, and Risk Management activities with focus on dFMEA’s.
• Conduct scientific literature reviews as part of Post-market Surveillance activities
How will you get here?
• A relevant degree within Bioengineering/BioMedical engineering at M.Sc level or Bachelor level with documented industrial experience
• Well versed in Design Control activities (21 CFR 820.30), Biological evaluation of medical device (ISO 10993) and Risk Management (ISO 14971)
• Knowledge with MDR an advantage but not a requirement
• Experience with cellular assays and hand-on experience in culturing mammalian cells
• Experience with IVF technologies an advantage, but not a requirement
• Highly motivated and posses’ good cooperation skills and an interest and aptitude in driving a project towards the goal
• Ability to summarize and transform data into action plans
• Ability to lead projects and coordinate with multiple functional areas
• Good at planning own work
• Effective communication and writing skills with ability to clearly present results and conclusions.
• Delegating and following up on delegated responsibilities
• Proficient English in writing and verbally
• Proficient Danish in writing and verbally
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 17.6.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Roskilde
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