At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Within the Renal Denervation (RDN) Design Assurance (DA) Laboratory at Medtronics 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 degreeAND minimum of 4 years of relevant experience OR Masters 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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.