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Medtronic Sr. Design Quality Engineer in Boulder, Colorado

Sr. Design Quality Engineer

Location:

Boulder, Colorado, United States

Requisition #:

2100024T

Post Date:

Feb 01, 2021

Position Description:

Sr. Design Quality Engineer, Covidien LP (a Medtronic company) in Boulder, CO. Provides quality engineering support for class II and class III medical device products. Applies knowledge of design control principles, statistics, process systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Responsible for design changes of released product in Patient Monitoring. Partners with Regulatory Affairs to provide input to and review of regulatory submissions. Navigates FDA QSR requirements and guidance including 21 CFR820 and ISO13485. Navigates industry regulations to include ISO14971 compliant Risk File including Risk Plans, Reports, Assessments, Failure Mode Effect Analyses and Post Launch Risk Assessments. Coordinates Testing and analyzing biocompatibility and sterilization assessing compliance to ISO 10993 and ISO 11135. Provides guidance for Verification Validation test plans, protocols, and reports and test method validations, including statistical analysis. Navigates IEC 62304 compliant software, software architecture and design as well as IEC 60601 Electromechanical designs. Coordinates Design for Reliability and Manufacturability (DRM), CAPA (Corrective and Preventive Action) and performing root cause analysis.

Basic Qualifications:

Masters degree in Mechanical, Industrial or Biomedical Engineering, or Bioengineering and two (2) years of experience in quality engineering for medical devices. Must possess a minimum of two (2) years of experience with each of the following:FDA QSR requirements and guidance including 21 CFR820 and ISO13485;ISO14971 compliant Risk File including Risk Plans, Reports, Assessments, Failure Mode Effect Analyses and Post Launch Risk Assessments; Testing and analyzing biocompatibility and sterilization assessing compliance to ISO 10993 and ISO 11135; Verification Validation test plans, protocols, and reports and test method validations, including statistical analysis; IEC 62304 compliant software, software architecture and design; IEC 60601 Electromechanical designs; andDesign for Reliability and Manufacturability (DRM),CAPA (Corrective and Preventive Action) andperforming root cause analysis.

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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