Bio and Materials development Engineer
Bio and Materials development Engineer
Location: Blue Ash - OH. 100% Onsite.
JD:
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 end-to-end product validation
Top Skills:
Materials engineering experience, Biomaterials and its process for using it in the Medical device design & development.
Years of Experience: 14.00 Years of Experience