Bio and Materials development Engineer Job Blue Ash area,Ohio USA,Engineering

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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