Prin Quality Engineer

Medtronic•Lafayette, MN

About The Position

We anticipate the application window for this opening will close on - 31 Dec 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 We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including: Creating and managing risk management plans and reports, as well as conducting regular risk reviews. Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts. Analyzing and reviewing product complaints to anticipate and prevent future issues. Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed. Implementing and maintaining robust product security measures to protect against potential vulnerabilities. Developing and managing post-market surveillance plans to monitor product performance and safety in the field. Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation Other potential responsibilities Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.

Requirements

Bachelor’s degree in Engineering, or a related technical field. Advanced degree preferred.
In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Nice To Haves

Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred.
Experience in Quality Assurance, Engineering, Capital equipment Industry Experience: Medical device industry.
Proficient in quality assurance practices, risk management, and regulatory compliance.

Responsibilities

Creating and managing risk management plans and reports, as well as conducting regular risk reviews.
Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures.
Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
Analyzing and reviewing product complaints to anticipate and prevent future issues.
Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed.
Implementing and maintaining robust product security measures to protect against potential vulnerabilities.
Developing and managing post-market surveillance plans to monitor product performance and safety in the field.
Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation
Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.
Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements.
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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)