Senior Quality Engineer
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
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.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 are working onsite a minimum of 4 days per week 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 role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
Within the Renal Denervation (RDN) Design Assurance (DA) Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all aspects of PDP from pre-market to post market product surveillance. We participate in the design process to ensure the performance and safety of the complex electromechanical devices we develop, is assured and maintained throughout the product lifecycle. This position is a combined role serving as both the equipment Subject Matter Expert (SME) and a lab support engineer, ensuring robust technical oversight and operational support for laboratory activities.
Responsibilities may include the following and other duties may be assigned:
- Serve as the SME for Design Assurance lab, supporting day-to-day lab activities as well as lab equipment activities
- Create and maintain lab operating procedures and work instructions in accordance with the Quality Management System (QMS) requirements
- Implement and configure the Laboratory Information Management Systems (LIMS)
- Procure, install, verify & validate Lab equipment
- Lead and support root cause investigations relating to test failures and any equipment issues
- Complete Equipment/Software development documentation including URS, Risk Assessment, IQ and EDST (OQ) documents, managing associated change order process
- Identify and drive continuous improvement projects within the lab
- Design and Develop tooling and fixturing to support Test Method development
- Collaborate with project teams to plan and schedule activities necessary to meet timelines
Required Knowledge and Experience:
- Experience working in the medical device or other regulated industry
- Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
Preferred Knowledge and Experience:
- Knowledge of FDA regulations and ISO 17025, as well as working in a regulated environment
- Experience in electrical engineering principles
- Experience of validating or developing Test Methods
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 and life stage.
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