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Bio and Materials development Engineer

TekWissen LLC
Blue, OH Full Time
POSTED ON 2/18/2025
AVAILABLE BEFORE 5/14/2025

Overview :

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. Our client is an American multinational information technology services and consulting company and is a leading provider of information technology consulting and business process outsourcing services dedicated helping the worlds leading companies build stronger businesses.

Title : Bio and Materials development Engineer

Work Location : Blue Ash OH 45242

Job Type : Contract

Work Type : Onsite

Duration : 12 Months

Job Description / Responsibilities :

  • 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 endtoend product validation

Top Skills :

  • Materials engineering experience Biomaterials and its process for using it in the Medical device design & development.
  • TekWissen Group is an equal opportunity employer supporting workforce diversity.

    Key Skills

    JSP,Building Construction,Downstream,Home Care,Art And Craft

    Employment Type : Full Time

    Vacancy : 1

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