| Company: | THERMO FISHER SCIENTIFIC |
|---|---|
| Job Role: | Medical Device Scientist. |
| Experience: | (1-5 years). |
| Vacancy: | 20+ |
| Qualification: | BE/B.Tech, ME/M.Tech, MBA. |
| Salary: | 5,22,000DKK./year. |
| Location: | Roskilde, Denmark. |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
Its annual revenue exceeds $25 billion, making it one of the world's largest science service companies. We are dedicated to helping our customers make the world a healthier, cleaner, and safer place. Our customers are looking to increase productivity in laboratories, improve patient diagnostics and therapies, or accelerate life sciences research. Through our industry-leading brands, such as Thermo Scientific, Applied Bio-systems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon, we offer an unmatched combination of innovative technologies, purchasing convenience, and pharmaceutical services. Visit www.thermofisher.com for more information.
The R&D manager will report to you, and you will be part of a R&D team with four scientists and three laboratory technicians. Cell culture consumables, immunology tools, and bio-production applications are among the group's key concentrations.
How will you make an impact?
Medical Device Scientists will be the "go-to person" for requests from our Operations, Quality Assurance, and Risk Analysis teams. QA and RA, as well as Post-market surveillance activities for Medical Device products, are integral parts of your role. For managing, developing, and manufacturing our medical devices, you will have to create Design History Files and Risk Management Files. For these activities, Design Control will be at the center, including the Development of the Biological Evaluation Reports for Medical Devices (and this will involve activities spanning the initiation of study reports (internal/external), to the writing of the reports. A range of products will be studied and you will be asked to develop data in the laboratory.
What will you do?
- Establish a multidisciplinary team to evaluate which technical data is relevant based on ISO standards
- Assist in developing Biological Evaluation Reports on a technical level.
- Plan and execute experiments, conduct evaluations, interpret results, and document the results in a Biological Evaluation Report.
- Be an active member of teams performing Design Controls and Risk Management activities with a focus on DFMEEs.
- Review of scientific literature as part of the Post-market Surveillance process
- A relevant degree within Bioengineering/Bio-Medical 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 devices (ISO 10993) and Risk Management (ISO 14971)
- Knowing MDR is a plus but not essential
- Hand-on experience in culturing mammalian cells and knowledge of cellular assays
- An advantage would be IVF technology experience, but that is not a requirement
- An ability to drive projects towards their goals with a strong sense of motivation and cooperative skills.
- Capacity for analyzing data and creating action plans
- Leadership and coordination skills across several functional areas
- Planning own work is a strong suit
- Ability to clearly convey findings and conclusions through effective communication and writing.
- Delegation and execution of delegated responsibilities
- Proficiency in writing and speaking English
- Written and verbal proficiency in Danish
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! http://jobs.thermofisher.com
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