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1+ months

Sr. Design Assurance Engineer

Medtronic
Santa Ana, CA 92702
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Sr. Design Assurance Engineer

Location:

Santa Ana, California, United States

Requisition #:

20000CHE

Post Date:

Aug 17, 2020


**Position Description:**

**Sr. Design Assurance Engineer for Medtronic, Inc. located in** **Santa Ana, CA** **. Provide quality design assurance engineering support to ensure thesuccessful development of Medtronic Medical Device products. Ensure designcontrol requirements are met and products are developed and manufactured inaccordance with applicable industry standards, regulatory requirements andcustomer requirements. Coordinates Risk systems and processes to include DesignFailure Mode Effects Critically Analysis (DFMECA), Process, Failure ModeEffects Critically Analysis (PFMECA) and User Failure Mode Effects CriticallyAnalysis (UFMECA). Performed all shelf life testing for new product developmentincluding Accelerated Aging shelf life and Real Time aging shelf life. Providesfor Variable and Attribute Test Method Development and Validation. Works todeliver Design Controls to include Product Performance Specifications, DesignVerification, Design Validation and Design Transfer. Coordinates Complaint andProduct Failure Investigations, pre and post market root cause analysis, Correctiveand Preventive Actions (CAPA) and Non- Conforming Material Requests (NCMR).Experience working in ISO Class 7 and 8 cleanrooms for implantable medicaldevices. Navigates the complexities or government and industry standards toinclude FDA CFR 21 part 820 requirements and ISO standards to include ISO13485, ISO 9001 and ISO 14971. Works with various statistical tools and Minitabsoftware to include DOE, ANOVA, Confidence and Tolerance Limits, Gage RR,Capability analysis and Six Sigma Methodology. Coordinates InstallationQualification /Operational Qualification and Performance Qualification(IQ/OQ/PQ) for Product Development and quality inspection.**


**Basic Qualifications:**

**Bachelors degree or foreignequivalent in Mechanical, Mechatronic, Industrial, or Biomedical Engineering,or closely related engineering degree and five (5) years of progressiveexperience with Quality Engineering. Must possess at least 2 years ofexperience in each of the following: Design Failure Mode Effects CriticallyAnalysis (DFMECA), Process Failure Mode Effects Critically Analysis (PFMECA)and User Failure Mode Effects Critically Analysis (UFMECA); Shelf life testingfor new product development; Variable and Attribute Test Method Development andValidation; Design Control Deliverables to include Product PerformanceSpecifications, Design Verification, Design Validation and Design Transfer; Complaintand Product Failure Investigations, pre and post market root cause analysis,Corrective and Preventive Actions (CAPA) and Non- Conforming Material Requests(NCMR); ISO Class 7 and 8 cleanrooms for implantable medical devices; FDA CFR21 part 820 requirements and ISO standards to include ISO 13485, ISO 9001 andISO 14971; statistical tools and Minitab software to include DOE, ANOVA,Confidence and Tolerance Limits, Gage RR, Capability analysis and SixSigma Methodology; and Installation Qualification /Operational Qualificationand Performance Qualification (IQ/OQ/PQ) for Product Development.**
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.

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Posted: 2020-08-20 Expires: 2020-09-27
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Sr. Design Assurance Engineer

Medtronic
Santa Ana, CA 92702

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