Bio and Materials development Engineer
Bio and Materials development Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- Quality review of Spec Engineering documentation (processes specifications etc.) for accuracy of content formatting and spelling/grammar. Maintain metrics on document rework and reason
- Draft and review documentation related to procedures special instruction reports and standards/gap assessments or Polymer SME review for WE001156 updates
- Convert the supplier names from existing supplier and split specification when multiple material are identified on a single specification
- Update / standardize reference standards and transfer them to WE001156 and Rename specification per WE0138 guidelines
- Find out the linked drawings or documents with existing material specification and link with updated material specification
- Facilitate document management and material specific engineering changes
- Update iMOE database with material and biocompatibility data (e.g. medical grade sustainable grade sterilization documentation chemicals risk assessments etc.)
- Product development support including support to regulatory team to provide documentation for approval process.
- Strong Knowledge about Biocom process.
- Gather supporting document for specification updates (e.g. COA/COC SDS etc.) for WE0138 process execution or regulatory requests (e.g. submissions tenders)
- Process the changes through the system per CP0150 (e.g. CRs CNs Mod Code listings)
- Preparation and quality review of biocompatibility documentation for EES R&D Biocompatibility
- Digitization/archival of biocompatibility files
- iMOE database updates to archive and integrate evaluation and chemical data.
- Mechanical Design (Medical Device) and development services
- Mechanical Engineering Material using medical grade plastics services
- Design and development of Buyers product and process development that meets product requirements
- Develop verification and validation strategies for endtoend product validation
- Materials engineering experience Biomaterials and its process for using it in the Medical device design & development.
Employment Type
Full Time
