What are the responsibilities and job description for the RD Sterile Disposable Engineer position at TekWissen LLC?
Overview :
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title : R&D Sterile Disposable Engineer
Location : Indianola PA 15051
Duration : 12 Months
Job Type : Contract
Work Type : Onsite
Job Description : Position purpose
The purpose of this contract engineering position is to support medium to large design and testing efforts pertaining to the development of new and innovative plastic sterile medical disposable products for radiology and cardiovascular devices.
This role participates in the product design and development of new products and may support life cycle engineering of existing products.
The individual will work as a member of a cross functional team that includes design manufacturing quality regulatory and program management in an FDA regulated environment.
Major tasks and responsibilities of position
Lead and / or support detailed engineering design development and implementation of new sterile disposable product designs utilized in radiology and cardiovascular medical procedures.
Conduct or direct testing in a Research and Development lab environment to verify concept product designs (including Samples preparation for Risk Reduction Testing Functional Testing etc.)
Support verification / validation testing of production intent products using novel product designs.
Create various design history file documentation throughout the product development process including technical assessments test protocols / reports and various engineering documentation.
Writes scientific protocols manages or performs the execution of the protocols analyzes results and writes reports.
Create and modify SD designs using CAD software such as Pro Engineer and CREO. CAD models may be 3D printed as required.
Works closely with other functions including engineering quality procurement and product supply to ensure project deliverables are properly planned and aligned with broader organizational objectives.
Other Duties as assigned.
Qualifications
B.S in Mechanical Biomedical or Plastics Engineering or related field.
1 3 years of industry experience directly pertaining to mechanical / plastic engineering roles.
Basic familiarity with medical device regulated design control process.
Excellent problemsolving skills creative thinker and interpersonal communication.
Ability to perform data analysis using Minitab.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Key Skills
Laboratory Experience,Vendor Management,Design Controls,C / C ,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development
Employment Type : Full Time
Vacancy : 1
