Medtronic
Overview
We anticipate the application window for this opening will close on - 10 Nov 2025. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life
The Principal Reliability Engineer role is part of the Cardiac Surgery Operating Unit. A Day in the Life In this role, you will support the Cardiac Surgery Post Market Quality organization with quality-related activities for the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. You will own the risk management file and related activities, lead root cause investigations and CAPAs, perform Health Risk Assessments, support Field Corrective Actions (FCAs), and conduct Post-Market Surveillance. You will collaborate with Quality, RPE, Regulatory, and Manufacturing colleagues to address product issues, compliance concerns, non-conformities, and cost-effective solutions. You will review DFMEAs, test methods, and test reports in compliance with design control and risk management procedures used in the medical device industry. You must be able to understand design and risk implications of changes and work cross-functionally in a fast-paced, multi-tasking team environment. We value diversity and inclusion and strive to create a culture where everyone can thrive. This position is in Mounds View, MN, within the Cardiac Surgery operating unit. On-site work is four days per week to foster professional growth and cross-functional collaboration. The role requires less than 10% travel to support project completion.
Responsibilities Risk Management: Support risk assessments and hazard analyses based on post-market data. Lead Health Risk Assessments to determine risk and recommend Field Corrective Actions if needed. Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, identify trends and potential issues. Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints; perform root cause analysis and support complaint trend investigations and quality signals from the field. Reporting: Prepare and present reliability reports and metrics; communicate findings to regulatory authorities as required. Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process, or supplier changes and corrective/preventive actions to enhance product reliability. Regulatory Compliance: Ensure activities comply with standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR) and company policies. Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance. Coaching: Mentor and coach junior engineers.
Qualifications – Must Have - Minimum Requirements Bachelor’s in Science, Technology, Engineering, Math or related technical discipline with a minimum of 7 years of technical experience, or a Master’s degree with a minimum of 5 years of technical experience Nice to Have Expertise in risk management Strong technical writing and clear communication skills for both technical and non-technical audiences Ability to manage multiple projects and timelines Problem-solving and innovative capabilities Quality experience in the Medical Device industry Knowledge of Microsoft Office and Windows OS Familiarity with regulations: FDA 21 CFR Part 820, ISO 13485, ISO 10012, ISO 17025
About Medtronic We lead global healthcare technology and boldly attack challenging health problems by searching out solutions. Our Mission is to alleviate pain, restore health, and extend life. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. Medtronic is an equal opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. We may require compliance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act for certain roles and locations. Physical Job Requirements: The physical demands described are representative of those that must be met to perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities. For office roles, daily work involves mobility and computer use along with interaction with peers and co-workers. Specific work conditions may vary by role; please consult with local HR for details.
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We anticipate the application window for this opening will close on - 10 Nov 2025. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life
The Principal Reliability Engineer role is part of the Cardiac Surgery Operating Unit. A Day in the Life In this role, you will support the Cardiac Surgery Post Market Quality organization with quality-related activities for the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. You will own the risk management file and related activities, lead root cause investigations and CAPAs, perform Health Risk Assessments, support Field Corrective Actions (FCAs), and conduct Post-Market Surveillance. You will collaborate with Quality, RPE, Regulatory, and Manufacturing colleagues to address product issues, compliance concerns, non-conformities, and cost-effective solutions. You will review DFMEAs, test methods, and test reports in compliance with design control and risk management procedures used in the medical device industry. You must be able to understand design and risk implications of changes and work cross-functionally in a fast-paced, multi-tasking team environment. We value diversity and inclusion and strive to create a culture where everyone can thrive. This position is in Mounds View, MN, within the Cardiac Surgery operating unit. On-site work is four days per week to foster professional growth and cross-functional collaboration. The role requires less than 10% travel to support project completion.
Responsibilities Risk Management: Support risk assessments and hazard analyses based on post-market data. Lead Health Risk Assessments to determine risk and recommend Field Corrective Actions if needed. Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, identify trends and potential issues. Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints; perform root cause analysis and support complaint trend investigations and quality signals from the field. Reporting: Prepare and present reliability reports and metrics; communicate findings to regulatory authorities as required. Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process, or supplier changes and corrective/preventive actions to enhance product reliability. Regulatory Compliance: Ensure activities comply with standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR) and company policies. Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance. Coaching: Mentor and coach junior engineers.
Qualifications – Must Have - Minimum Requirements Bachelor’s in Science, Technology, Engineering, Math or related technical discipline with a minimum of 7 years of technical experience, or a Master’s degree with a minimum of 5 years of technical experience Nice to Have Expertise in risk management Strong technical writing and clear communication skills for both technical and non-technical audiences Ability to manage multiple projects and timelines Problem-solving and innovative capabilities Quality experience in the Medical Device industry Knowledge of Microsoft Office and Windows OS Familiarity with regulations: FDA 21 CFR Part 820, ISO 13485, ISO 10012, ISO 17025
About Medtronic We lead global healthcare technology and boldly attack challenging health problems by searching out solutions. Our Mission is to alleviate pain, restore health, and extend life. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. Medtronic is an equal opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. We may require compliance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act for certain roles and locations. Physical Job Requirements: The physical demands described are representative of those that must be met to perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities. For office roles, daily work involves mobility and computer use along with interaction with peers and co-workers. Specific work conditions may vary by role; please consult with local HR for details.
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