Sr. Design Assurance Engineer- (Hybrid) - Santa Ana, CA Job at Medtronic
Careers That Change Lives
The
Sr. Design Assurance Engineer will be responsible for R&D and commercial product and component functional/mechanical laboratory testing for the Structural Heart business. As a member of the Design Assurance team, you will have primary responsibility for influencing product quality and reliability outcomes across commercial products and design transfers from R&D into manufacturing and distribution.
Do meaningful work, make a difference, and improve lives — starting with your own.
Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in.
-Structural Heart and Aortic
The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta
A Day in the Life: Responsibilities may include the following and other duties may be assigned.
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Develops, coordinates, and conducts technical product/design validation/verification studies and evaluations of engineering design concepts.
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Integral member of product design and development teams responsible for leading activities required to ensure reliability and quality of the design. Supports ongoing global regulatory compliance including submissions and audits (MDR, ISO 13485, FDA CFRs, etc.).
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Recommends design or test methods and procedures for achieving required levels of product reliability and compliance to industry standards. Leads test equipment selection, qualification, validation, Gage R&R, and ongoing calibration and preventive maintenance for the Structural Heart R&D testing laboratory in Mounds View, MN. Supports the expansion of testing capabilities and facilities.
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Completes hazards and risk analysis studies of design and processes using ISO 14971, FMEA, and other risk management principles.
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Compiles and analyzes complaints, performance reports, and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
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Drives CAPA and Nonconformance investigations and ensures that corrective measures meet acceptable standards. Works cross-functionally to achieve optimal results.
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Analyzes preliminary plans and develops quality assurance programs to achieve company, customer and governmental agency reliability objectives.
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Ensure Design Requirements Flow down, predictive modeling, and DRM (Design for Reliability and Manufacturability) are applied.
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As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
This an on-site, hybrid position which is located in Santa Ana, CA.
MUST HAVE: MINIMUM REQUIREMENTS:
To be considered for this role, please ensure the minimum requirements are evident on your resume.
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Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have:
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CQE – Certified Quality Engineer
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CRE – Certified Reliability Engineer
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PMP – Project Management Professional
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)
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)
This role is hybrid-remote (~50% onsite) with proximity to Mounds View Minnesota. Must have ability to travel ~10%, including internationally.
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