Sr. Product Engineer

Location:

Mounds View, Minnesota, United States

Requisition #:

21000498

Post Date:

Feb 16, 2021


JOB DUTIES:


Sr. Product Engineer for Medtronic Inc., at its facility in Mounds View, MN. Provides sourcing support for the new product development and sustaining projects both in Post Market and Pre-Market space. Brings expertise and provide guidance to the business and the external suppliers in executing against Medtronic Quality system elements. Ensure system level projects programs work to include plans, requirements, specifications, tests, test results, traceability, risk documents and reports. Utilizes and Implements DRM (Design, Reliability and Manufacturing) Tools and methodology with-in all new product development programs. Lead Component and Product Qualifications, Interpret GDT (Geometric Dimensioning and Tolerancing), Test Method Validations (Gage Repeatability Reproducibility). Process Validations (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Provides Data Analysis and Inferencing. Supplier controls, supplier auditing, statistical quality control, protocol report preparation, non-conforming product controls, Control Plans, Risk activities to include DFMEA and PFMEA. Navigates external regulations and standards to include ISO13485, ISO9001, ISO 14971 and FDA CFR 21 part 820. Understands and utilizes Good Manufacturing Practices in medical device environment.


REQUIREMENTS:


Requires a Masters degree in Biomedical, Electrical, Mechanical or closely related engineering field and 1 year of experience with Product or Supplier Quality Engineering and one (1) year of post-bachelors progressive experience in all of the following: DRM (Design, Reliability and Manufacturing) Tools and methodology within new product development programs; Component and Product Qualifications, Interpret GDT (Geometric Dimensioning and Tolerancing), Test Method Validations (Gage Repeatability Reproducibility); Process Validations (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)); Statistical Data Analysis and decision making; Supplier controls, supplier auditing, statistical quality control, protocol report preparation, non-conforming product controls, Control Plans, Risk activities to include DFMEA and PFMEA; ISO13485, ISO9001, ISO 14971 and FDA CFR 21 part 820; Good Manufacturing Practices in medical device environment.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.