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 Medical device design & development.