Post Market Quality Engineering Manager

MedtronicFridley, MN
Onsite

About The Position

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neuromodulation Operating Unit provides advanced therapies for chronic pain, movement disorders, and other neurological conditions. Through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems, we deliver personalized treatments that restore function, reduce symptoms, and improve quality of life worldwide. Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions In this exciting role as a Post Market Quality Engineering Manager, you will have responsibility for many aspects overseeing product quality and reliability for medical devices that are released as part of the Medtronic Neuromodulation organization. In this role, you will oversee investigation of issues and analysis of risks for products in the field. This includes trends in complaint data, labeling, software, and hardware related issues. You will also provide risk and reliability engineering support for released product design and process changes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.

Requirements

  • Bachelor’s degree in engineering or science field with a minimum of 5+ years of experience in quality and/or engineering in the Medical Device or related industry
  • Advance degree in engineering or science field with 3+ years of experience in quality and/or engineering in the Medical Device or related industry
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

  • 3+ Years of Engineering Management experience
  • Experience working in a regulated industry (e.g., FDA-regulated)
  • Master’s Degree in Engineering, Quality, Regulatory, or related.
  • Experience in Medical devices – specifically in Neuromodulation devices is preferred
  • Experience with Field Corrective Actions
  • Experience in medical devices or other highly regulated industry such as defense or automotive.
  • Experience in quality, reliability, design assurance, safety, or systems engineering.
  • Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.).
  • Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
  • FDA regulatory experience- e.g., presenting during FDA inspections, responding to regulatory inquiries
  • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
  • Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.
  • Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships
  • Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude
  • Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
  • High degree of initiative and ability to motivate a team
  • Strong attention to detail and accuracy
  • Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks
  • Strong analytical skills and the ability to solve problems through analytical reasoning.
  • ASQ Certification in Quality or Reliability is a plus.
  • Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications is a plus.
  • Self-Starter with a sharp focus on quality and customer experience

Responsibilities

  • Lead the post-market quality engineering team supporting commercially released products, specifically focused on the Spinal Cord Stimulator Therapy.
  • Oversee assessment, investigation, and resolution of product complaints, nonconformances, and field performance issues.
  • Drive root cause investigations and corrective/preventive actions in partnership with cross-functional teams including R&D, manufacturing, regulatory, clinical, medical safety, and supply chain.
  • Monitor post-market quality trends, analyze data, and identify emerging risks or signals requiring escalation.
  • Support product surveillance activities, including complaint trending, field corrective actions, and risk management updates.
  • Ensure timely and compliant execution of quality processes related to complaint handling, CAPA, NCMR, change control, and field actions.
  • Partner with Regulatory Affairs to support reportability assessments and post-market regulatory obligations, as applicable.
  • Support external inspections and internal audits by providing quality engineering expertise and documentation.
  • Review and approve investigations, technical assessments, and quality records to ensure they are complete, accurate, and compliant.
  • Drive continuous improvement initiatives to strengthen post-market processes, product quality, and customer experience.
  • Develop team capability through coaching, prioritization, workload management, and performance development.
  • Provide management with regular updates on quality metrics, key risks, and progress against critical actions.

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)
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