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
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If you're ready to take your career to the next level as a Sr. Risk Management Specialist at Medtronic, Inc. in Fridley, Minnesota, we want to hear from you! You'll be at the forefront of ensuring the safety of our medical devices throughout their lifecycle. In this role, you're not just identifying risks but actively engaging with a diverse team to evaluate, control, and prevent potential hazards that could arise during the use of medical devices. Your expertise will shine as you evaluate product and system designs while applying risk control mitigations to minimize failure occurrences. You'll be utilizing tools like Microsoft Office Suite, MS Project, and Minitab in your daily tasks. Your ability to perform thorough risk management deliverables—such as conducting Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis—will be critical in supporting design control processes, covering everything from Product Performance Specifications to Design Validation. You'll also dive deep into investigations surrounding complaints and product failures, using your strong analytical skills for root cause analysis and strategic CAPA development. Familiarity with FDA and ISO regulations is essential as you'll navigate these standards to ensure compliance at all stages. This position also offers flexibility, as we welcome telecommuters who can work within a reasonable distance from our Fridley site. With a competitive salary range of $120,200 to $152,400 per year and a comprehensive benefits package, you'll be well-supported in your journey with Medtronic. Join us, and make a difference in healthcare by ensuring our medical devices are safe for patients worldwide!
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