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Sr. Biomedical Engineer

Medtronic
Northridge, CA 91325
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Sr. Biomedical Engineer

Location:

Northridge, California, United States

Requisition #:

21000PD1

Post Date:

Mar 24, 2022


**Careers That Change Lives**


As a member of the Medtronic Diabetes Continuous Glucose Monitoring (CGM) Sensor RD team, you will be supporting different phases of next generation CGM product development. You will be responsible for developing test methodology to conduct material, component, and device level testing to ensure products meet specifications and regulatory requirements. You will conduct verification and validation activities inclusive of creating protocols, testing per approved protocols, and documentation activities in accordance with applicable development and regulatory requirements. In this role the individual will be interfacing with other RD functions, regulatory, quality, reliability, and clinical teams as appropriate.


**A Day in the Life**


In this role, the individual will be responsible for conducting experimentation/testing to generate quality data to enable sound decision making to advance various sensor programs. There will be strong emphasis on Design for Reliability and Manufacturability (DRM) principles, problem solving methodologies (DMAIC), and process capability analysis. This individual will be expected to perform independently and is responsible for experimental process design, data analysis, collaborating within and across functions, and writing technical documentation and where appropriate present the outcomes and updates to larger audiences.


Specific Responsibilities include:


+ Collaborate with internal and external partners to identify and evaluate technologies that enable future generation products.

+ Research and development of novel short-term and long-term sensor and wearable technologies that enable product innovation pipeline.

+ Create performance, design, and process specifications.

+ Develop test methods and strategies to support early feasibility, characterization, and qualification of processes.

+ Document protocols and reports at various stages of product development.

+ Coordinate with cross-functional teams in planning, designing, and executing clinical studies to gather relevant data for down selecting specific designs/sub-components

+ Design and develop advanced new test methods, improve existing test methods, measurement techniques, and fixtures.

+ Develop verification and validation test strategies and equipment to enable the execution of product testing and perform analysis to evaluate designs for short and long-term performance and reliability.

+ Present information to cross functional audiences and management.

+ Review and approve document change requests (DCRs) for design, materials, and process documentation.

+ Manage internal and external customers/vendors.

+ Ensure designs meet and exceed product specifications, regulatory requirements, national and international standards.

+ Independently plan, manage, and prioritizes tasks/projects.

+ Contribute to development of continuous glucose monitoring subsystems as relevant to the group goals


**Must Have: Minimum Requirements**


**To be considered for this role, please ensure the minimum requirements are evident on your resume.**


Bachelors of Science in Biomedical Engineering, Chemical Engineering or related Engineering field with 4+ years of professional experience;


OR


Masters of Science in Biomedical Engineering, Chemical Engineering, or related Engineering field with 2+ years of professional experience;


**Nice to Have**


+ Medical Device Industry Experience

+ Experience in product design and development in an RD environment

+ Experience in mechanical and/or electrochemical systems

+ Direct experience in characterization, design of experiments and data analysis methodologies (T-test, ANOVA and significance testing at a minimum)

+ Knowledge about in-vitro and in-vivo testing of subcutaneous medical devices

+ Exposure to DMAIC or equivalent Scientific Method problem solving for root cause analysis efforts

+ Experience with gage RR studies, demonstrating process capability (Ppk Cpk), and Qualification procedures (IQ/OQ/PQ)

+ Experience with statistical analysis of data (Ex. Minitab, JMP, Matlab, etc.)

+ Experience with technical documentation (Ex. laboratory notebooks, publications, engineering reports, IQ/OQ/PQs, Standard Operating Procedures, test protocols, etc.)

+ Capable of working on multiple projects in a deadline driven environment

+ Greenbelt in DRM, Six Sigma

+ Cleanroom procedural experience

+ Good understanding of CFR 21 820 FDA Quality System Regulation, GMP, GDP, ISO 13485, EU Medical Device Directives and other applicable quality system regulatory standards


**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Physical Job Requirements**

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 to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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: 2022-03-08 Expires: 2022-06-05
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Northridge, CA 91325

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Biomedical Engineer
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Overall Rating: 29/199
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