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Sr. Product Engineer


Louisville, CO 80027
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Job Details

Sr. Product Engineer


Louisville, Colorado, United States

Requisition #:


Post Date:

Dec 06, 2020

**Position Description:**

**Sr. Product Engineer for Medtronic, Inc. in Louisville, CO. Sr. ProductEngineer is responsible for developing new or improving existing manufacturingprocesses to produce high-quality medical devices. Prepare Process Verificationand Validation (PVVP) Plan and summary, and Design Verification and Validation Protocolsand reports.** **Compile data and definechanges required in testing equipment, testing procedures, manufacturingprocesses and new testing requirements. Provide hardware and software testingto include debug troubleshooting, write and execute test protocols andreports. Provide analysis for Electronic component composition, standards,process, and properties. Develop and release non-product equipment designspecifications, assessments and requirements. Develop, execute, and releasenon-product Software validation documentation, Design Failure Mode EffectsAnalysis (DFMEA), Process Failure Mode Effects Analysis (PFMEA). Develop andexecute Installation Qualification (IQ), Operation Qualification (OQ),Performance Qualification (PQ), and Gage RR. Navigates FDA Quality SystemRegulations, Medical Device Directive, ISO 13485, ISO 14971, and IEC-60601.Coordinate Corrective and Preventive Action (CAPA) as well as Riskdocumentation development. Utilize MiniTab, Lean Six Sigma methodologies, andDesign for Reliability and Manufacturability (DRM) principles. Supportdevelopment of processes, test equipment, electro-mechanical assembly andequipment installation and validation. Run Electronic test equipment to includeOscilloscope and Voltmeters. Utilize robotic system and electromagneticequipment. Understand Certified Body File, Electrical Safety ratings,Electro-Magnetic Interference and Compatibility. Utilize box-buildcapital systems production to include low volume and high mix environments.**

**Basic Qualifications:**

**Mastersdegree in Industrial, Mechanical or Electrical Engineering or related engineeringfield, and two (2) years experience in manufacturing engineering. Must possessa minimum of 2 years of experience with each of the following: FDA QualitySystem Regulations, Medical Device Directive, ISO 13485, ISO 14971, andIEC-60601; Corrective and Preventive Action (CAPA); Risk documentationdevelopment; MiniTab, Lean Six Sigma methodologies, and Design for Reliabilityand Manufacturability (DRM) principles; development of processes, testequipment, electro-mechanical assembly and equipment installation andvalidation; electronic test equipment to include Oscilloscope and Voltmeters; roboticsystem and electromagnetic equipment; Certified Body File, Electrical Safetyratings, Electro-Magnetic Interference and Compatibility; and Box-buildcapital systems production environments.**
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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