R&D Engineer for Chemical & Physical Analysis of Medical Devices
Convatec
- Osted, Sjælland
- Permanent
- Fuldtid
You will be working with the development of new test methods for testing chemical and physical compatibility between drugs (Biologics or small molecules), steel, and polymers used in our devices in accordance with state-of-the-art. You will drive compliance by working with the validation of test methods and related equipment.You will utilize the developed test methods in projects, to assure compatibility between specific drugs and devices. Weekly, you will coordinate and participate in physical testing with the internal laboratory in Osted, and coordinate chemical testing with our internal laboratory in Deeside in Wales and external suppliers.Your closest collaborations will be with our Product Quality Engineers, Quality Assurance Engineers, Mechanical Engineers, and Clinical and Biocompatibility specialists.You will be responsible for data analyses and reporting of results, as well as communicating results. Additionally, you will use your expertise to support different teams within Business Development, Product Development, Sustaining Engineering, and Quality Assurance. The drug and device compatibility SME is a central role in an exciting company in constant growth.Key responsibilities:
- Develop and maintain data on chemical and physical compatibility between relevant drug ingredients, steel, and polymers.
- Drive compliance documents such as procedure updates related to Drug and Device compatibility.
- Plan, coordinate, and review tests of new product designs for design verification and stability studies.
- Participate as a Drug & Device Compatibility SME in business development, product development projects, feasibility studies, quality audits, and alike.
You understand the importance of good documentation practices and see the value in creating solid documentation of test methods and supporting documentation.Qualifications:We expect you to have a master’s or bachelor’s degree in STEM or a similar technical diploma, with at least 3 years of relevant experience.
- You have experience and knowledge within Medical Devices or Pharma development.
- You have a material understanding of polymers, steel, and drug interactions.
- You have experience with the validation of methods according to EU ISO 13485, US 21CFR820, or similar regulations.
- You have knowledge of statistical analysis like ANOVA, T-test, GR&R, P/T ratio, DOE using SAS JMP, Minitab or alike.
- Further knowledge of US and European standards will be an advantage.
- You have excellent written and verbal communication skills in English.