What are the responsibilities and job description for the Bio and Materials development Engineer position at Ztek Consulting INC?
Job Title : Bio and Materials development Engineer
Duration : 6-12 months
Location : Onsite Blue Ash - OH
Work Type :
Rate : Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
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 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.
ABOUT Ztek :
Website : www.ztekinc.com
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek's diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.
Disclaimer :
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hrd@ztekinc.com Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.
