Senior Quality Engineering Manager

MedtronicMounds View, MN
Hybrid

About The Position

As a Senior Quality Engineering Manager in the Cardiac Surgery Post Market Quality organization, you will lead quality strategy and execution for a complex, global commercial portfolio. You will be accountable for ensuring patient safety, product performance, and regulatory compliance for released products, while leading a high-performing team responsible for post-market surveillance and risk management. This role requires deep technical expertise in risk management, design controls, and root cause investigation, along with proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast-paced environment. At Medtronic, bold ideas are brought forward with speed and decisiveness to put patients first. In-person exchanges are considered invaluable, and the team works onsite a minimum of 4 days per week to foster professional growth and cross-functional collaboration. The role will require less than 10% travel.

Requirements

  • Baccalaureate degree AND minimum of 7 years of relevant experience with 5+ years of managerial experience OR Advanced degree AND minimum of 5 years of relevant experience with 5+ years of managerial experience
  • 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
  • Deep technical expertise in risk management, design controls, and root cause investigation
  • Proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast-paced environment

Nice To Haves

  • Experience managing a large team preferably in Post Market Quality Engineering, Design Assurance Engineering, or Operations Quality Engineering
  • Working knowledge of global regulatory requirements and experience supporting regulatory inspections or audits
  • Demonstrated strong influencing skills with the ability to drive alignment and decisions across functions and leadership levels
  • Ability to balance technical depth with strategic thinking to drive risk-based decision making

Responsibilities

  • Lead and develop a team of Reliability Engineers supporting all aspects of post-market quality; manage performance, talent development, and succession planning
  • Oversee product and process risk management activities, including hazard analyses, FMEAs, and risk/benefit assessments, aligned with system architecture, clinical intent, and real-world use
  • Lead and/or coach team on investigations into product failures, complaints, and quality signals from the field, applying robust root cause analysis and ensuring timely, effective CAPAs
  • Provide Quality leadership and governance for design verification and validation, including review and approval of test strategies, protocols, execution readiness, and results
  • Partner cross-functionally to improve product performance and oversee design and process changes for released products
  • Establish and sustain standard work, operating mechanisms, and KPIs to improve execution rigor, visibility, and predictability
  • Identify risks, gaps, and improvement opportunities within Quality processes and lead continuous improvement initiatives to enhance compliance, efficiency, and technical rigor

Benefits

  • Competitive Salary and flexible Benefits Package
  • 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)
  • Paid sick time (for temporary employees, as required under applicable state law)
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