Sr. Risk Management Specialist

About the position

The Sr. Risk Management Specialist for Medtronic, Inc located in Fridley, MN is responsible for ensuring the safety of finished medical devices throughout the product lifecycle. This role involves engaging a cross-functional group to identify, evaluate, control, and prevent failures that can result in hazards when people use medical devices. The specialist will evaluate product and system design to identify risk control mitigations to reduce failure occurrence. Key tasks include utilizing computer and software packages such as MS Office Suite, MS Project, and Minitab, and performing Risk Management Deliverables including Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. The position also supports design control deliverables, including Product Performance Specifications, Design Verification, Design Validation, Design Transfer, and Usability and Human Factor Engineering. The specialist will approve product drawings/prints and provide support for Variable and Attribute Test Method Development and Validation. Additionally, the role involves supporting Complaint and Product Failure Investigations, pre and post market root cause analysis, Corrective and Preventive Actions (CAPA), and Product Non-Conformances. The specialist will navigate government and quality regulations, including FDA 21 CFR part 820 requirements and ISO 13485, ISO 14971, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA). The position allows for telecommuting from home within reasonable commuting distance from Fridley, MN, but will require physical presence at the worksite several days a week.

Responsibilities

• Ensure the safety of finished medical devices throughout the product lifecycle.
• Engage a cross-functional group to identify, evaluate, control, and prevent failures.
• Evaluate product and system design to identify risk control mitigations.
• Utilize MS Office Suite, MS Project, and Minitab for risk management tasks.
• Perform Risk Management Deliverables including Use, Design and Process FMEA and Product Hazard Analysis.
• Support design control deliverables including Product Performance Specifications, Design Verification, Design Validation, and Design Transfer.
• 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 MDR.

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 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, ISO 14971, EU MDR, and 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
• Capital Accumulation Plan (available to Vice Presidents and above)