Bio and Materials development Engineer

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 materials 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 documents 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.

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