Design Quality Engineer II - Test Method Validation
Careers That Change Lives
In this exciting role as a Design Quality Engineer II - Test Method Validation, you will have primary focus on supporting new product development and test method validation for the Neurovascular business within the Brain Therapies Group. As a member of the Design Assurance Engineering team, you will have primary responsibility for influencing product quality and reliability outcomes across new product development projects.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
Responsibilities may include the following and other duties may be assigned.
- Actively represent Quality Engineering function on product development teams for Test Method Validation
- Mentor less senior Quality Engineers and technicians
- Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including those for Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification, and Risk Management.
- Hands on participant in early stages of product development including but not limited to physician interaction, component engineering, competitive product and prototype testing.
- Identifies quality characteristics and validation criteria for components, subassemblies, and finished devices.
- Ensure product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements.
- Drive predictive engineering methodology principles (DRM) incorporating reliability and capability analysis assessments in Design and Manufacturing processes.
- Travel less than 25%
Must Have: Minimum Requirements
Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality
- Experience with test method validation including destructive and non-destructive variable R&R, Type 1 and Attribute studies.
- Experience with vascular devices, embolic coils, stents and/or catheters
- Design, Reliability and Manufacturability (DRM) and/or Design for Six Sigma (DFSS)
- Experience with Risk Management
- Self-motivated, driven and committed to a team approach
- Strong interpersonal, organizational and project management skills
- Strong oral, presentation and technical writing skills
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)
