Sr. Reliability Engineer

Position Description

Sr. Reliability Engineer for Medtronic, Inc located in Brooklyn Park, MN. Provide reliability engineering support the new product development lifecycle for medical devices. Develop and support the risk mgmt. architecture, Design for Reliability and Manufacturability (DRM) targets. Support design and phase reviews, design transfer for software and hardware. Review design, change specifications, and plan against contractual and process requirements. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Utilize selective Software Reliability Prediction Model for the Cardiac Surgery Business to improve reliability. Navigate the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union Medical Device Regulation (EU MDR), ISO 14971, and IEC 62304. Support design control deliverables to include Product Performance Specifications, Design Verification & Design Validation Testing (DVT), Design Phase Reviews, Design Transfer, and Human Factor Engineering. Provide support for Variable and Attribute Test Method Development and Validation. Support pre-market team with complaint prediction and predictive field performance. Utilize statistical analysis tools to analyze data, such as Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Utilize computer and software packages to include MS Office Suite, Prochain, Requs AI Predict, Agile, and Minitab. Relocation assistance is not available for this position. #LI-DNI

The position will be onsite at least 4 days per week at the Brooklyn Park, MN location.

NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:

Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Basic Qualifications

Master’s degree in Mechanical, Industrial or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing, systems or reliability engineer for medical devices.

Must possess at least two (2) years’ experience with each of the following: 21 CFR Part 820 QSR, ISO 13485, EU MDR, ISO 14971, and IEC 62304; Design Control Deliverables to include Product Performance Specifications, software systems requirements, DVT, Design Phase Reviews, Design Transfer, and Human Factor Engineering; Variable and Attribute Test Methods Development and Validation; Complaint prediction and predictive field performance; ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; and MS Office Suite, Prochain, Requs AI Predict, Agile, and Minitab.

The position is located at Medtronic, Inc., 7611 Northland Drive, Brooklyn Park, MN 55428.

The position will be onsite at least 4 days per week at the Brooklyn Park, MN location.

Salary: $106,400 to $159,600 per year

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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: https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic