What are the responsibilities and job description for the Bio and Materials development Engineer position at Smart IT Frame LLC?
Role : Bio and Materials development Engineer
Location : Blue Ash - OH. 100% Onsite
Duration : Long Term
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 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 : 10.00 Years of Experience
