Bio and Materials development Engineer

TechDigital Group; Blue Ash (OH); On-site; USD 85,000 - 125,000; Full time

Job summary

An established industry player is seeking a detail-oriented engineer to ensure the accuracy of engineering documentation related to medical devices. This role involves quality reviews, documentation drafting, and regulatory support, all crucial for product development. The ideal candidate will have strong knowledge in materials engineering and biocompatibility processes, contributing to innovative solutions in medical device design. Join a collaborative team focused on enhancing product quality and compliance, making a significant impact in the medical field. If you are passionate about engineering and regulatory processes, this opportunity is perfect for you.

Qualifications

• Strong knowledge of biocompatibility processes and materials engineering.
• Experience in medical device design and regulatory documentation.
• Knowledge of Biocom process.

Responsibilities

• Review and maintain engineering documentation for accuracy and compliance.
• Support product development and regulatory approval processes.
• Convert 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 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).
• 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) for WE0138 process execution or regulatory requests.
• 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.

Skills

Materials engineering

Biomaterials

Medical device design

Regulatory documentation

Biocompatibility

Tools

iMOE database

Job description

JD:

1. Quality review of Spec Engineering documentation (processes, specifications, etc.) for accuracy of content, formatting, and spelling/grammar. Maintain metrics on document rework and reason.
2. Draft and review documentation related to procedures, special instruction, reports, and standards/gap assessments or Polymer SME review for WE001156 updates.
3. Convert the supplier names from existing supplier and split specification when multiple materials are identified on a single specification.
4. Update / standardize reference standards and transfer them to WE001156 and rename specification per WE0138 guidelines.
5. Find out the linked drawings or documents with existing material specification and link with updated material specification.
6. Facilitate document management and material specific engineering changes.
7. Update iMOE database with material and biocompatibility data (e.g., medical grade, sustainable grade, sterilization documentation, chemicals, risk assessments, etc.).
8. Product development support including support to regulatory team to provide documentation for approval process.
9. Strong knowledge about Biocom process.
10. Gather supporting documents for specification updates (e.g., COA/COC, SDS, etc.) for WE0138 process execution or regulatory requests (e.g., submissions, tenders).
11. Process the changes through the system per CP0150 (e.g., CRs, CNs, Mod Code listings).
12. Preparation and quality review of biocompatibility documentation for EES R&D Biocompatibility.
13. Digitization/archival of biocompatibility files.
14. iMOE database updates to archive and integrate evaluation and chemical data.
15. Mechanical Design (Medical Device) and development services.
16. Mechanical Engineering – Material using medical grade plastics services.
17. Design and development of Buyers product and process development that meets product requirements.
18. 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.