Principal Design Assurance Quality Engineer
Santa Rosa, CA
In this excited role as a Principal Design Assurance Quality Engineer, you will use your high level technical and leadership skills to advance the development of innovative products to treat aortic disease. The engineer will apply technical rigor in device reliability as well as leadership of the extended team to deliver ground breaking new therapies. Responsibilities will focus on the development of robust risk management, design reliability, requirements development, project management, failure analysis, regulatory submission and documentation.
CVG
The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
AORTIC, PERIPHERAL AND VENOUS (APV) offers treatment for vascular abdominal and thoracic aortic disease, interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies and venous therapeutic solutions for superficial and deep vein diseases.
A Day in the Life
Providing leadership for engineers supporting new product development.
Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Completes risk analysis studies of new design and parts.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
As necessary, proposes changes in design 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.
Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
Nice to Have
Experience in a highly regulated industry in early phase development.
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)
