Senior Quality Engineering Manager

MedtronicMinneapolis, MN
1dOnsite

About The Position

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 Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The Senior Engineering Manager - Sustaining Quality will play a critical leadership role ensuring the ongoing quality, reliability, and compliance drug-device combination products and critical components manufactured at our Fridley, MN (Rice Creek) site. This role offers the opportunity to lead experienced engineering teams, influence cross‑functional strategy, and make a direct impact on patient safety and product excellence. Leadership Expectations: This role requires a people‑first leader who demonstrates strong judgment, clear communication, and collaborative influence while developing talent and delivering results in a complex, regulated environment. You will provide senior leadership for sustaining quality engineering activities in a highly regulated manufacturing environment, balancing people leadership, technical judgment, and cross‑functional influence . At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

  • Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of leadership experience
  • OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of leadership experience

Nice To Haves

  • Experience supporting drug‑device combination products
  • Familiarity with FDA QMSR, ISO 13485, and 21 CFR Part 211
  • Lean, Six Sigma, or similar continuous improvement experience
  • #LI-DNI
  • 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.

Responsibilities

  • Lead and develop a team of Quality Engineers supporting the manufacture of drug‑device combination products and components
  • Own sustaining quality strategies to ensure products remain compliant, reliable, and fit for use throughout their lifecycle
  • Provide leadership for nonconformance management, CAPA, risk management, and product investigations in a combination‑product environment
  • Partner closely with Manufacturing, R&D, Operations, Supplier Quality, Regulatory, and other Quality teams to resolve complex quality and compliance issues
  • Drive continuous improvement initiatives using data, risk‑based decision making, and quality system metrics
  • Ensure compliance with FDA, ISO, and other applicable product requirements and global regulations
  • Serve as a key voice of quality for the Rice Creek site, influencing site strategy and execution
  • Coach, mentor, and develop engineering leaders and technical talent to support long-term organizational success

Benefits

  • Medtronic offers a competitive Salary and flexible Benefits Package
  • A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. 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)
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