Sr. Risk Management Specialist

Position Description:

Sr. Risk Management Specialist for Medtronic, Inc located in Fridley, MN. Responsible for ensuring the safety of finished medical devices throughout the product lifecycle. Engage a cross-functional group to identify, evaluate, control, and prevent failures that can result in hazards when people use medical devices. Evaluates the product and system design to identify risk control mitigations to reduce failure occurrence. Utilize computer and software packages to include MS Office Suite, MS Project, and Minitab. Perform Risk Mgmt. Deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. Support design control deliverables to include Product Performance Specifications, Design Verification, Design Validation, Design Transfer, and Usability and Human Factor Engineering; approve product drawings/prints; provide support for Variable and Attribute Test Method Development and Validation. Provide support for Complaint and Product Failure Investigations, pre and post market root cause analysis, Corrective and Preventive Actions (CAPA) and Product Non-Conformances. Navigate government and quality regulations to include FDA 21 CFR part 820 requirements and ISO 13485, ISO 14971, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA). Apply probability concepts towards occurrence rate calculations in Product Hazard Analysis. *Multiple positions available. **Eligible for telecommuting from home within reasonable commuting distance from Fridley, MN. Will require physical presence at worksite in Fridley, MN at least several days a week. ***Employer will accept any suitable combination of education, training or experience. Relocation assistance is not available for this position.  #LI-DNI

Basic Qualifications:

Master's degree in Mechanical, Industrial or related Engineering field, or Industrial Studies. Requires three (3) years of experience as a Reliability or Quality Engineer. Experience must include three (3) years of post-Bachelor's progressive experience in all of the following: Risk Mgmt. Deliverables including Use, Design and Process FMEA, and Product Hazard Analysis; Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering; Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Product Non- Conformances; FDA 21 CFR 820, ISO 13485, and ISO 14971 European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA); Application of statistics for risk estimation.

Alternate Qualifications:

Bachelor's degree in Mechanical, Industrial or related Engineering field, or Industrial Studies. Requires five (5) years of post-Bachelor's progressive experience as a Reliability or Quality Engineer. Experience must include five (5) years of post-Bachelor's progressive experience in all of the following:  Risk Mgmt. Deliverables including Use, Design and Process FMEA, and Product Hazard Analysis; Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering; Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Product Non-Conformances; FDA 21 CFR 820, ISO 13485, and ISO 14971 European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA); Application of statistics for risk estimation.

Position reports to Medtronic, Inc. 7000 Central Ave NE, Fridley, MN 55432

Salary: $120,200.00 to $152,400.00 per year

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 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:

Medtronic benefits and compensation plans

Use this link to hyperlink

https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic