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Carlsbad, California - USD Full Time Posted: Monday, 19 June 2017
 
 
Systems Supplier Quality Engineer - Ventilation

The Systems Supplier Design Quality Engineer provides quality engineering support in design and development of medical device products, specifically ventilators. The Systems Supplier Quality Engineer also facilitates the application of design controls in product development and sustaining changes, as well as provides support in the rapid resolution of product complaints and/or safety issues.

Key Responsibilities:

. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.

. Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs.

. Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).

. Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.

. Provide guidance and direction for sample size and statistical analysis of verification and validation test results.

. Utilize Statistics stools experience eg Minitab.

. Provide training to project teams on procedures, verification, validation, statistical methods and design controls.

. Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.

. Review Design History Files and Technical Files for conformance to applicable requirements.

. Assist, when appropriate with internal and supplier audits.

. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

. Support the Regulatory Department in writing technical submissions.

. Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix.

. Other duties as assigned with or without accommodation.

Required Qualifications:

. Bachelor's degree in quality engineering, mechanical engineering, electrical engineering or related degree

. 10+ years of quality engineering experience

. 6+ years of medical device engineering experience

. Strong familiarity with regulatory requirements (eg ISO 13485,CFR 820 & EN ISO 14971)

. Familiarity with EN ISO 60601-1, EN ISO 60601-1- 8, EN ISO 80601-2- 12 a distinct advantage.

. Experience in risk evaluation techniques, eg HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.

. Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis.

. Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis

. Material Analysis, Design of Experiments & Reliability Analysis.

. ASQ CQE, CRE, CSQE certification desirable, but not essential.

. Good verbal and written communication skills including protocol/report development and technical presentations.

. Risk Management, ISO 14971, FTA, FMEA, HACCP.

. Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA.

. Test plan development and root cause failure analysis.

Preferred Qualifications:

. Master's degree in quality engineering, mechanical engineering, electrical engineering or related degree

. Previous experience working in a cross-functional team environment.

. ASQ CQE, CQA, CSQE and/or CRE certification.

. Familiar with statistical software tools (Minitab, Stat Graphics, Statistic),

. Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.

. Familiar with IEC 60601 and product specific industry standards.

. Familiar with DMAIC or DMADV(DFSS) methodologies

. DFSS/Lean Green Belt or Black Belt

Physical Job Requirements:

Normal Office and lab Conditions. Must be able to operate a computer and a telephone. Some minimal amount (15%) of travel by plane and car may be required. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities.

ABOUT MEDTRONIC:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

EEO STATEMENT:

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Posted by StartWire



Carlsbad, California, United States of America
Engineering
USD
Medtronic Inc.
Medtronic Inc.
JS2124_3F33B9561620F80D716B8D460E1EF9D5_228_I/228122245
6/19/2017 5:55:29 AM

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