Sr. Risk Management Specialist

About the position

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

Responsibilities

• Ensure 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.
• Evaluate product and system design to identify risk control mitigations to reduce failure occurrence.
• Utilize MS Office Suite, MS Project, and Minitab for risk management deliverables.
• Perform Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis.
• Support design control deliverables including 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.
• Support Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Product Non-Conformances.
• Navigate government and quality regulations including FDA 21 CFR part 820, ISO 13485, ISO 14971, and EU Medical Device Regulation (MDR).
• Apply probability concepts towards occurrence rate calculations in Product Hazard Analysis.

Requirements

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

Nice-to-haves

• Bachelor's degree in Mechanical, Industrial or related Engineering field, or Industrial Studies.
• Five (5) years of post-Bachelor's progressive experience as a Reliability or Quality Engineer.

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)