Sr. Biomedical Engineer
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Medical Device Industry Experience
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Experience in product design and development in an R&D environment
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Experience in mechanical and/or electrochemical systems
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Direct experience in characterization, design of experiments and data analysis methodologies (T-test, ANOVA and significance testing at a minimum)
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Knowledge about in-vitro and in-vivo testing of subcutaneous medical devices
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Exposure to DMAIC or equivalent Scientific Method problem solving for root cause analysis efforts
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Experience with gage R&R studies, demonstrating process capability (Ppk & Cpk), and Qualification procedures (IQ/OQ/PQ)
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Experience with statistical analysis of data (Ex. Minitab, JMP, Matlab, etc.)
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Experience with technical documentation (Ex. laboratory notebooks, publications, engineering reports, IQ/OQ/PQ’s, Standard Operating Procedures, test protocols, etc.)
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Capable of working on multiple projects in a deadline driven environment
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Greenbelt in DRM, Six Sigma
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Cleanroom procedural experience
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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. Let’s 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)