Senior Design Assurance Engineer - SH&A
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Structural Heart and Aortic integrated operating unit offer 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.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This position is based in Santa Rosa, CA
Role and Responsibilities
Excellent interpersonal skills and communication skills are a must. Overall responsibilities will be for the design, development, and implementation of testing methods and equipment, as well as input to the program risk management files and testing strategy.
In general, the following responsibilities apply to the Senior Design Assurance Engineer role. This includes, but is not limited to the following:
- 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.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Completes risk analysis studies of new design and processes.
- Lead as a quality extended team member responsible for driving design, development, and implementation of testing methods and equipment.
- Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
- Participate in risk management activities including system risk analysis (ISO14971), Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety.
- Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, test results, verification and validation reports.
Must Have, Minimum Requirements:
To be considered for this role, please be sure the minimum requirements are evident on your resume
- Bachelor’s degree required in Engineering, Science, or a related technical field.
- Minimum of 4 years of technical experience in Quality or Engineering,
- Or advanced degree with 2 years of technical experience in Quality or Engineering.
Nice to Have
- Medical device industry experience
- Quality Engineering experience
- ASQ-CQE, CQA, CBA or equivalent certifications
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career
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