Bio and Materials Development Engineer

Creative Solutions Services, LLC; Blue Ash (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled Bio and Materials Development Engineer to enhance their team. This role involves ensuring the quality of engineering documentation, supporting product development for medical devices, and managing biocompatibility data. The ideal candidate will have extensive experience in materials engineering and a strong understanding of biomaterials processes. Join this innovative company where your expertise will directly contribute to the success of cutting-edge medical solutions and improve patient outcomes. If you are passionate about engineering and dedicated to quality, this opportunity is perfect for you.

Qualifications

• 14 years of experience in materials engineering and biomaterials for medical devices.
• Strong knowledge of biocompatibility processes and documentation.

Responsibilities

• Quality review of engineering documentation for accuracy and standards.
• Support product development and regulatory documentation processes.

Skills

Materials engineering

Biomaterials

Document management

Biocompatibility documentation

Mechanical Design

Tools

iMOE database

Job description

Bio and Materials Development Engineer #25-18206

Blue Ash, OH All On-site

Job Description

Bravens Inc., a wholly owned subsidiary of Ampcus Inc., is an information technology consulting and services company. Bravens is a leader in providing tailored staffing solutions across both IT and non-IT industries. We are in search of a highly motivated candidate to join our talented team and contribute to our ongoing success.

Job Title: Bio and Materials Development Engineer

Location(s): Blue Ash, OH

Job Summary:

• 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 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 Required:

Materials engineering experience, Biomaterials and its process for using it in the Medical device design & development.

Experience:

• 14 Years of Experience.

Bravens is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.