Medtronic · 7 hours ago
Risk Management Engineer II -Neuro
Minneapolis, MN
Full-time
Hybrid
Entry, Mid Level
$84K/yr - $126K/yr
2+ years expMedtronic is a leader in healthcare technology, committed to alleviating pain and restoring health. They are seeking a Risk Management Engineer to drive the development of safe and effective implantable medical systems, collaborating with multidisciplinary teams to evaluate and improve product safety and reliability.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis
Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted
Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated
Evaluate impact of potential issues to patient safety and product performance
Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle
Identify and act upon opportunities for continuous improvement of the Risk Management Process
Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance
Create documentation in compliance with applicable procedures to meet project deliverables
Qualification
Required
Requires an Engineering Baccalaureate degree and minimum of 2 years of relevant experience OR a Master's degree with a minimum of 0 years relevant experience
Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis
Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted
Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated
Evaluate impact of potential issues to patient safety and product performance
Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle
Identify and act upon opportunities for continuous improvement of the Risk Management Process
Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance
Create documentation in compliance with applicable procedures to meet project deliverables
Preferred
Degree in biomedical engineering or a related technical field
Background in a highly regulated industry, ideally with implantable medical devices
Strong leadership and collaboration skills, with the confidence to voice informed opinions and the emotional intelligence to build consensus across teams
Self-driven and proactive, with a demonstrated ability to take initiative, work independently, and follow through without the need for constant direction
Critical thinker and problem solver, skilled at connecting information from diverse sources to generate insights and drive innovative solutions
Growth-oriented mindset, eager to learn, experiment with new ideas, and adapt in a dynamic, fast-paced environment
Experience applying statistical methods
Familiarity with regulatory standards such as 21 CFR Part 820 (Quality System Regulation) and ISO 13485
Knowledge of Risk Management principles (ISO 14971) and techniques such as Design Failure Mode and Effects Analysis
Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
Experience working with or alongside Design, Quality, Regulatory, Clinical and/or Manufacturing teams
Understanding of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and other robust design practices
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO
Linnea Burman
SVP & President, Neurovascular
Recent News
Business Standard India
2025-12-29
2025-12-27
Company data provided by crunchbase