20 days old

Materials Engineer

Medtronic
Mounds View, MN 55112
  • Job Code
    14965011
Position Description:
Materials Engineer for Medtronic, Inc. located in Mounds View, MN. Develop and execute the biocompatibility analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable Medtronic products. Coordinate with cross-functional groups to develop biocompatibility strategy, assemble current design documentation, provide gap assessments and verification reports to remediate in accordance with international standards. Conduct laboratory testing and write technical reports to document device & component compliance with necessary regulations and materials characterization requirements. Responsible for various materials testing including infrared spectroscopy and optical microscopy to show material equivalency, processing and analysis for use in medical devices. Utilize process tools to include DOE (Design of Experiment), SPC (Statistical Process Control), risk activities using FMEA (Failure Mode Effects and Analysis), QSR (Quality Systems Requirement), and technical writing. Navigate and comply with various international and domestic regulations associated with biocompatibility to include ISO 10993, ISO 13485, ISO 14971 standard and materials regulations including EU Medical Device Regulations, California Proposition 65, and EU Restrictions of Hazardous Substances. Develop medical device, including materials characterization, biocompatibility, and biostability. Utilize CAPA and root cause analysis to solve materials related issues and recommend mitigation strategies. Leverage Biocompatibility testing of methods using analytical chemistry, in vitro and in vivo biological testing.

Basic Qualifications:
Master's degree in Materials Engineering, Mechanical Engineering, Medical Device Innovation, or related engineering field; and six (6) months of experience with Materials Engineering for Medical Devices. Must possess a minimum of six (6) months of experience with each of the following: Materials testing, processing and analysis; DOE, SPC, FMEA, QSR, and technical writing; ISO 10993, ISO 13485, ISO 14971 and materials regulations including EU MDR, California Proposition 65, and EU RoHS; Conducting materials characterization, biocompatibility, and biostability for medical device development; CAPA and Root Cause analysis of materials issues, and developing mitigation strategies; and Biocompatibility testing of methods to include analytical chemistry, in vitro, and in vivo biological testing.





Posted: 2023-01-10 Expires: 2023-02-08
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Materials Engineer

Medtronic
Mounds View, MN 55112

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