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.

Basic Qualifications:

Masters 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 will be onsite at least 4 days per week at the Brooklyn Park MN location.

Salary: $106400 to $159600 per year

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